Article

A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea

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Abstract

Objective To compare the effectiveness of positional therapy (PT) with the sleep position trainer (SPT) to oral appliance therapy (OAT) in patients with mild-to-moderate positional obstructive sleep apnea (POSA). Methods Multicenter, prospective, randomized, controlled trial. Patients with mild-to-moderate POSA (apnea-hypopnea index (AHI) ≥5 ≤30/hour sleep) were randomized for PT or OAT. Polysomnography was repeated after 3 months. Efficacy, adherence, mean disease alleviation (MDA), quality of life, dropouts and adverse events were evaluated. Results A total of 177 patients were screened for the study; 99 underwent randomization and 81 completed the study. Intention-to-treat (ITT) analysis of median [IQR] AHI showed a reduction in the PT group from 13.0 [9.7-18.5] to 7.0 [3.8-12.8], p<0.001 and in the OAT group from 11.7 [9.0-16.2] to 9.1 [4.9-11.7], p<0.001. Mean adherence (≥4 hours/night, ≥5 days/week) was 89.3 ± 22.4% for SPT versus 81.3 ± 30.0% in OAT patients, p=0.208. Conclusions Oral appliance therapy and positional therapy were equally effective in reducing the median AHI in patients with mild-to-moderate POSA. The results of this study have important implications for future OSA treatment guidelines and daily clinical practice.

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... However, only a few studies on PTDs have reported significant differences in arousal index [11,12], awakenings [13], percentage of stage N1 sleep (%N1; shallow sleep), and percentage of stage N2 sleep (%N2; shallow sleep) [12] between baseline polysomnography (PSG) and PTD-set PSG. Most research on PTDs has shown no significant differences in sleep efficiency [6,[11][12][13][14][15], arousal index [6,13], awakenings [6,11,13], %N1 [6,13,16], %N2 [6,11,13,16], percentage of stage N3 sleep (%N3; deep sleep) [6,[11][12][13]16], and percentage of rapid eye movement (REM) sleep (%REM) [6,11,13,16], which suggests that the effects of PTD on sleep quality are not yet well-established. In addition, these studies have not evaluated detailed arousals. ...
... Some investigators conducting field research have found significant effects of PTDs on arousal index [11,12], awakenings [13], and %N1 and %N2 [12], whereas others have found no significant changes in sleep efficiency [6,[11][12][13][14][15], arousal index [6,13], awakenings [6,11,13], %N1 [6,13,16], %N2 [6,11,13,16], %N3 [6,[11][12][13]16], and %REM [6,11,13,16] between patients using and not using a PTD. Similarly, OAs were reported to have no significant effect on sleep efficiency or sleep architecture in adult patients with OSA despite reducing the arousal index from the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (ADSM) clinical practice guideline for OSA with an OA [20]. ...
... In a randomized, controlled trial on PTD and OA treatments, investigators reported a significant reduction from 13.9 ± 5.9 at baseline to 8.7 ± 7.4/h at 3 months in a PTD group, and from 13.2 ± 6.0 to 8.1 ± 5.9/h in an OA group, indicating that PTD and OA are equally effective for reducing AHI [14]. Another randomized controlled trial revealed similar [15]. ...
Article
Full-text available
PurposeThe purpose of this study was to elucidate the effect of a neck-worn position therapy device (PTD) and oral appliance (OA) on sleep parameters in patients with obstructive sleep apnea (OSA).Methods Patients with an apnea hypopnea index (AHI) of 5/h or more at baseline polysomnography were divided into a PTD group and an OA group randomly. All participants underwent a type 1 polysomnography for diagnosis and device-set outcome measurements.ResultsThe PTD decreased the AHI from a mean of 24.2/h to 16.7/h, and the OA decreased the AHI from 20.8/h to 10.3/h. Snoring duration decreased from 31.1% to 16.9% in the PTD group, and from 41.2% to 30.7% in the OA group. There were no significant differences in these decreases between the two groups. The PTD decreased sleep-time percentage in the supine position from a mean of 67.4% to 4.5%, despite five patients who were unable to avoid the supine position. There were no significant differences in improvement in sleep efficiency, percentage of stage wake, stage N1, stage N2, and stage REM, and overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.ConclusionPTDs are a potential treatment modality that does not disturb sleep in patients with OSA.
... The degree of OSA is commonly classified using the apnea-hypopnea index (AHI) by measuring the mean number of apneas and hypopneas within the hours of sleep. According to the AHI system, OSA can be classified as mild (AHI 5-15), moderate (AHI [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30], or severe (AHI >30) [4]. ...
... Therefore, for the purpose of comparing studies using MADs as a treatment method for OSA, a uniform definition of treatment success had to be established. Furthermore, the reliability of the main result could be questioned due to the fact that six studies (Benoist et al. [25], Keyf et al. [27], Kaur et al. [29], Phillips et al. [32], Schütz et al. [34], and Sutherland et al. [35]) reported a successful treatment outcome for all participants. Nevertheless, this could be explained by the small number of participants in three of the studies (Keyf et al. [27], Kaur et al. [29], and Schütz et al. [34]) or because of the use of the same MAD (SomnoDent) in the other three studies (Benoist et al. [25], Phillips. ...
... Furthermore, the reliability of the main result could be questioned due to the fact that six studies (Benoist et al. [25], Keyf et al. [27], Kaur et al. [29], Phillips et al. [32], Schütz et al. [34], and Sutherland et al. [35]) reported a successful treatment outcome for all participants. Nevertheless, this could be explained by the small number of participants in three of the studies (Keyf et al. [27], Kaur et al. [29], and Schütz et al. [34]) or because of the use of the same MAD (SomnoDent) in the other three studies (Benoist et al. [25], Phillips. et al. [32], and Sutherland et al. [35]). ...
Article
Objective: Oral appliance therapy is a non-invasive treatment that offers a wide variety of oral devices for the treatment of obstructive sleep apnea (OSA). The present review focuses on the effectiveness of mandibular advancement devices for the treatment of OSA. Methods: A systematic review based on the PRISMA checklist was carried out. A detailed electronic database search was conducted using “Obstructive sleep apnea” AND “Oral appliance” AND “Dentistry” as keywords. Results: The initial search in the electronic databases resulted in a total of 262 papers. After the title and abstract analysis and full-text review, the number of eligible papers was reduced to 15. Conclusion: The mandibular advancement device is an effective treatment, improving the Apnea Hypopnea Index and the symptoms of patients with OSA in 92% of the subjects from all the investigated studies. The future may include the integration of a biosensor for the diagnosis and follow-up. Abbreviations: OSA: Obstructive sleep apnea; MADs: Mandibular advancement devices; CPAP: Continuous positive airway pressure; OAT: Oral appliance therapy; MRD: Mandibular repositioning devices; MAS: Mandibular advancement splints; MAA: Mandibular advancement appliances; OA: Oral appliances; AASM: American Academy of Sleep Medicine; AHI: Apnea-hypopnea index; EEG: Sleep-related breathing disorder SRBD; Electroencephalogram; EOG: Electrooculogram; ECG: Electrocardiogram; QOL: Quality of life; TMJ: Temporomandibular joint.
... In their study, Quinnel et al. [22] compared a nontitratable, customised device with two other appliances: a customised appliance made by a dental technician on models realised from dental records worn by patients with a specific kit and another preformed device ("boil and bite"). Other studies used a customised and titratable appliance [26][27][28][29][30][31][32][33][34][35]. Another important difference in these studies can be noted by observing the different duration of the follow-up periods (from 1 to 42.7 months) and the different severity of the respiratory index of the included patients (Table 1). ...
... Only one study compared different degrees of mandibular advancement [23]. Finally, a study compared the surgical approach (UPPP) with the oral appliance treatment [24], and one of the 17 studies compared the positional treatment with the oral appliance treatment [28]. None of these studies had a placebo group. ...
... MAD reported that compliance was always higher than the CPAP compliance. Only in two RCTs [28,30], a microsensor was used for a better compliance assessment in OA treatment. A study [30] showed a strong correlation between the International Journal of Dentistry sensor-reported compliance percentage and the self-reported compliance percentage (96.1% vs 100%) in the MAD group treatment. ...
Article
Full-text available
Background: Recent clinical guidelines have extended indications for oral appliances to subjects affected by moderate-to-severe obstructive sleep apnoea (OSA). The aim of this systematic review covering this important issue for public health is twofold: updating and summarizing the best available scientific evidence by selecting RCTs of quality only, and identifying the therapeutic pathways that can be transferred to the current clinical practice. Methods: All the abstracts which were published before February 18, 2019, have been identified in three electronic databases (PubMed, Web of Science, and Cochrane). The Cochrane Collaboration's tool for assessing risk of bias was used as an assessment tool in order to evaluate the quality of the selected studies. Results: The search strategy yielded 2,260 studies. After removing duplicates and studies that did not comply with the inclusion criteria, 32 full-text articles were assessed for eligibility, and 17 RCTs were finally included in the qualitative synthesis. The 17 selected studies were very heterogeneous in the type of included RCTs in terms of patient inclusion criteria, sample size, distribution of the two genders in the various groups, duration of treatment, and definition of primary and secondary outcomes, without any restriction on the definition of the control group. A common finding was the positive responsiveness of oral appliance treatment in subjects affected by mild-to-moderate OSA with some evidence for cases of severe OSA. Conclusion: Higher-quality studies are needed in order to provide additional useful guidelines for dental clinicians for OSA management.
... Positional-OSA patients can also be efficaciously treated with supine avoidance therapy (SAT), whereby the overall OSA severity is typically reduced to the magnitude measured in the non-supine positions [16][17][18] . The new A c c e p t e d M a n u s c r i p t generation of SAT devices, which utilize vibro-tactile feedback rather than position restriction to elicit the behavioral response, deliver improved outcomes and compliance in positional-OSA patients [16][17][18][19][20][21][22] . ...
... Despite these improvements in SAT technologies, it remains underutilized relative to OAT in positional-OSA patients, despite the fact that SAT and OAT effectiveness and compliance were reportedly similar [19][20][21] . The combination of OAT and SAT, which demonstrated superior outcomes compared to either therapy alone, is also underutilized 22 . ...
... year useful life and equivalent long-term compliance 19,20 . Medical insurance reimbursement for OAT in the United States ranges from $2,000 to $2,500. ...
Article
Full-text available
Aim: Produce empirical support for further enhancements to a therapy selection protocol for obstructive sleep apnea (OSA) patients intolerant of positive airway pressure. Methods: A retrospective analysis was conducted in 101 men and 69 women patients. Two-night home sleep apnea studies were conducted at baseline and with a trial oral appliance. Twenty-minutes in-position sleep was required to compute supine and non-supine apnea-hypopnea indexes (AHI). Data analyses were applied after stratification by sex and response to oral appliance therapy (OAT), and the results used for to calculate incremental cost-effectiveness ratios (ICER). Results: Compared with men, women had significantly lower pre-treatment supine and non-supine AHI values (p < 0.05). OAT non-responders had higher non-supine AHIs, resulting in less positional-OSA and more cases with severe OSA (P < 0.05). Across the cohort, 21% had positional-OSA with a pre-treatment non-supine AHI <5 events/h. In those who met this criterion, supine avoidance therapy (SAT) could have reduced the AHI values more than OAT by an average of 33% (P < 0.0001). The ICER for SAT instead of OAT in this group was negative, a condition that only occurs when one therapy is both less expensive and more effective than the other. A greater proportion of non-responders had post-OAT overall AHI ≥10 events/h with residual positional-OSA compared with responders (P < 0.0001). Combination therapy could reduce the AHI values by an average of 68%, resulting in ICER estimates five-times less than the reimbursement decision-making threshold. Conclusions and limitations: Based on pre-treatment non-supine AHI values, SAT would provide a superior first-line treatment outcome as compared to OAT in 21% of patients diagnosed with OSA. SAT would also provide a cost-effective adjuvant to OAT in an additional 15% of cases. The benefit of SAT could not be determined in one-fifth of the cohort who slept exclusively supine.
... Two studies that had used only the FOSQ did not show a significant change in quality of life. The study by Ruiter et al. [44] was a 2-year follow-up of the study by Benoist et al. [40]. The authors had pitted the sleep position trainer against the oral appliance. ...
... The authors believe that this was because of a delay in patient intake due to change in the location of appliance fitting, which might have caused reduced patient commitment. While the quality of life mildly improved, no clinically significant value was obtained [40,44]. ...
... Customized appliances are made by registering the patient's bite, whereas thermoplastic appliances are fabricated by placing the heated material in the patient's mouth and asking them to bite on it in an ideally advanced position. The thermoplastic appliances are a less expensive and less time consuming alternative to customized appliances [40,44]. A randomized crossover trial found a lower rate of treatment success and lower patient adherence associated with thermoplastic appliances. ...
Article
Full-text available
PurposeTreatment of patients with obstructive sleep apnea (OSA) using mandibular advancement appliances enhances the airway and may be an alternative to continuous positive airway pressure (CPAP) in individuals with reduced adherence to CPAP therapy. The effectiveness as well as improved patient compliance associated with these appliances may improve the quality of life in patients with OSA. The aim of this systematic review of studies was to determine the improvement in quality of life amongst patients with OSA who were treated with an oral appliance. Methods The research study was registered on the International Prospective Register of Systematic Reviews (PROSPERO: CRD42021193386). A search was carried out using the search engines Google Scholar, PubMed, Ovid, Cochrane Trial Registry, and LILACS. Patients with OSA treated with oral appliance therapy to advance the mandible were studied. Twenty-five studies were identified through the literature search and all had varying control groups for assessment of quality of life. Seventeen studies were included for the quantitative synthesis.ResultsQoL, evaluated by the Functional Outcomes of Sleep Questionnaire (FOSQ), significantly improved in patients treated with oral appliance therapy. There was a mean difference of 1.8 points between the baseline scores and the scores following treatment with an oral appliance.Conclusion Overall, a significant improvement in the QoL was observed with the Functional Outcomes of Sleep Questionnaire, following oral appliance therapy.
... In an additional 30% of the patients, the apneic events are higher in supine than in non-supine position, not reaching 50% difference [11]. For patients with mild to moderate POSA, oral appliance therapy (OAT) is among the first-line treatments, while positional therapy and surgery can be considered as well [12,13]. OAs are widely used and often result in decreased AHI and oxygen desaturations (ODIs) with clinical improvement in excessive daytime sleepiness and snoring [14]. ...
... This study is part of a randomized controlled trial in which OAT was compared with a position trainer in patients with POSA [12,13]. Participants were eligible for enrollment if they had mild or moderate POSA, were 18 years or above, and were able to provide informed consent. ...
... This study is a sub-assessment of the OAT therapy group in the POSA trial [12,13], focusing on the standardized stepwise titration protocol used. The POSA trial is a multicenter, prospective randomized controlled trial. ...
Article
Full-text available
PurposeIn patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.Methods This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.ResultsIn total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1–16.7) to 6.9 (3.7–10.3) (P < 0.001), and median objective adherence was 97.4 (61.4–100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.Conclusions This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.
... 19 The adult adherence rate for sleep position trainer use is relatively high and is as effective as oral appliance therapy in reducing the apnea-hypopnea index in POSA patients. [20][21][22] For children who struggle with CPAP compliance, positional therapy could be beneficial; however, it is infrequently recommended in children compared with adults. 23,24 Recognizing that POSA is common in adults and that positional therapy is a treatment option, the objective of this study was to evaluate the role positional therapy might play for obese children, who are less likely to be cured after a T&A. ...
... 13 More recently, some studies include a minimum duration of time spent in supine sleep before being diagnosed with POSA. 15,21 In our investigation, 48% of the children with persistent OSA were diagnosed with POSA under Cartwright's definition of an OAHI at least twice as high in the supine position compared with the nonsupine position. Verhelst et al. published a prevalence of only 19% also using Cartwright's definition of POSA. ...
Article
Full-text available
Study objectives: To determine if positional therapy is a viable treatment alternative for obese children with persistent OSA. Methods: A retrospective review was performed of children who underwent an adenotonsillectomy for OSA from 2014 to 2017. Children were included if they had a BMI≥95th percentile and had a post-operative polysomnogram. Subjects fell into one of three categories: mixed sleep (presence of ≥30 minutes of both non-supine and supine sleep), non-supine sleep, and supine sleep. Cure was defined as an obstructive apnea/hypopnea index (OAHI) of < 1 events/hour. Paired T-tests were used to assess the differences, and a linear model adjusting for obesity class, age at procedure, and sex was performed to assess the differences between non-supine and supine sleep. Results: There were 154 children that met the inclusion criteria. Using a paired t-test, supine sleep position had a significantly higher average OAHI (7.9 events) compared to non-supine (OAHI of 4.1), p-value <0.01 for the 60 children with mixed sleep. There were 43 children with predominantly non-supine sleep and 33 with predominantly supine sleep, and a McNemar's test comparing these children showed that those sleeping in the non-supine position were significantly more likely to be cured than those in the supine position (p<0.001). Conclusions: Sleep physicians and otolaryngologists should be cognizant of positional treatment when consulting with families and note that the postoperative PSG may be inaccurate if it does not include supine sleep. Positional therapy as a potential treatment option for obese children with persistent OSA following adenotonsillectomy warrants further investigation.
... As mentioned earlier, for PICOs 7 and 8, 1632 studies were originally identified, but only one study was finally selected for PICO 8 [88,89] . No statistically significant differences between both therapies (no p-value) was given. ...
... Similarly, MMO can be an alternative for patients experiencing CPAP failure [106]. Finally, despite very low certainty of evidence, patients with mild to moderate position-dependent OSA can be treated with vibratory positional therapy as compared to CPAP or as compared to mandibular advancement [83,84,88,89]. ...
Article
Full-text available
Treatment of obstructive sleep apnoea (OSA) in adults is evolving, as new therapies have been explored and introduced in clinical practice, while other approaches have been refined or reconsidered. In this European Respiratory Society (ERS) guideline on non-continuous positive airway pressure (CPAP) therapies for OSA, we present recommendations determined by a systematic review of the literature. It is an update of the 2011 ERS statement on non-CPAP therapies, advanced into a clinical guideline. A multidisciplinary group of experts, including pulmonary, surgical, dentistry and ear–nose–throat specialists, methodologists and patient representatives considered the most relevant clinical questions (for both clinicians and patients) relating to the management of OSA. Eight key clinical questions were generated and a systematic review was conducted to identify published randomised clinical trials that answered these questions. We used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess the quality of the evidence and the strength of recommendations. The resulting guideline addresses gastric bypass surgery, custom-made dual-block mandibular advancement devices, hypoglossal nerve stimulation, myofunctional therapy, maxillo-mandibular osteotomy, carbonic anhydrase inhibitors and positional therapy. These recommendations can be used to benchmark quality of care for people with OSA across Europe and to improve outcomes.
... Van Maanen et al. showed that PT with a new positional device, the Sleep Position Trainer (SPT), effectively reduces disease severity in mildto-moderate POSA [26,27]. PT has also been compared to oral appliances, and short-and long-term results show similar efficacy in mild-to-moderate POSA patients [28,29]. Since the majority of non-apneic snorers are position dependent, these subjects may potentially benefit from PT. ...
... The SPT has been tested before in mild-to-moderate POSA patients by Van Maanen et al. and showed encouraging short and long-term results [26,27]. These promising results in OSA patients were in line with other studies [28,42]. The advantages of new-generation PT include that, in case it is not effective after a trial period, the device can be returned and side effects are limited. ...
Article
Full-text available
Purpose: To evaluate the effect of a new-generation positional device, the sleep position trainer (SPT), in non-apneic position-dependent snorers. Methods: Non-apneic position-dependent snorers with an apnea-hypopnea index (AHI) < 5 events/h were included between February 2015 and September 2016. After inclusion, study subjects used the SPT at home for 6 weeks. The Snore Outcome Survey (SOS) was filled out by the subjects at baseline and after 6 weeks, and at the same time, the Spouse/Bed Partner Survey (SBPS) was filled out by their bed partners. Results: A total of 36 participants were included and 30 completed the study. SOS score improved significantly after 6 weeks from 35.0 ± 13.5 to 55.3 ± 18.6, p < 0.001. SBPS score also improved significantly after 6 weeks from 24.7 ± 16.0 versus 54.5 ± 25.2, p < 0.001. The severity of snoring assessed with a numeric visual analogue scale (VAS) by the bed partner decreased significantly from a median of 8.0 with an interquartile range (IQR) of [7.0-8.5] to 7.0 [3.8-8.0] after 6 weeks (p = 0.004). Conclusions: Results of this study indicate that positional therapy with the SPT improved several snoring-related outcome measures in non-apneic position-dependent snorers. The results of this non-controlled study demonstrate that this SPT could be considered as an alternative therapeutic option to improve sleep-related health status of snorers and their bed partners.
... 1 For patients with positional OSA (POSA), the new generation of positional therapy (PT) devices (i.e., vibrotactile feedback to neck or chest) hold promise, based on efficacy and improved compliance, compared to the traditional positional restraints (i.e., using tennis-balls) when used alone or potentially when used in combination with oral appliance therapy. [2][3][4][5] The proportion of OSA patients who might benefit from PT is estimated to range 56% to 75% depending on supine and non-supine sleep disordered breathing (SDB) severity and time spent in the supine position, as well as age, ethnicity, the definition used to score hypopneas, and the criteria used to characterize POSA. 2,3,[6][7][8] The first to fully characterize the influence of sleeping position on OSA severity was Cartwright, who defined POSA patients as those who had a supine AHI at least twice that in the non-supine position. ...
... 24,25 Finally, strong evidence has demonstrated that the new generation of PT devices are effective in reducing the AHI in the short term,and because these devices can monitor PT compliance, evidence of long term effectiveness is growing. 3,5,[26][27] Future investigations are also needed todetermine if POSA characteristic and/or criterion can be used to identify those who are more likely to be long term compliant with these new generation PT devices. 28,29 This study provided a systematic comparison of methods that characterize POSA in an effort to improve the identification of those who would likely benefit from PT. ...
Article
Full-text available
Abstract Objective/Background Systematically compare four criteria for Positional Obstructive Sleep Apnea (POSA) based on AASM 2007 and 2012 hypopnea scoring definitions. Patients/Methods 142 records acquired by in-home polysomnography (Sleep Profiler PSG2TM) were retrospectively analyzed using AHI based on the American Academy Sleep Medicine 2007 and 2012 criteria (AHI2007 and AHI2012). Positional obstructive sleep apnea (POSA) was characterized using four criteria: Amsterdam Positional OSA Classification (APOC), supine AHI twice the non-supine AHI (Cartwright), Cartwright plus the non-supine AHI <5 (Mador), and the overall AHI severity at east 1.4 times the non-supine severity (Overall/NS-AHI). Results Correlations between the Cartwright and Overall/NS-AHI criteria increased with the inclusion of a more relaxed definition of hypopneas (AHI2007=0.79 and AHI2012=0.86, P<0.00001). The prevalence of POSA based on the Cartwright and Overall/NS-AHI criteria was approximately 60% in those with at least mild OSA by AHI2007and AHI2012. A 16% reduction in POSA prevalence for AHI2012 vs. AHI2007 was attributed to the increased incident of mild OSA. For identificatio of those expected to have 25% or 35% reductions in SDB severity with positional therapy, Cartwright and Overall/NS-AHI exhibited the strongest sensitivity and Overall/NS-AHI and Mador the best specificity. Conclusions The four criteria used to identify POSA have similarities and differences. While there were similarities between the Cartwright and Overall/NS-AHI criteria in the detection of POSA prevalence across both scoring criteria, the Overall/NS-AHI provided the most consistent detection of those most likely to demonstrate important reductions in sleep disordered breathing severity if supine sleep is avoided.
... In dieser Untersuchung zum Einfluss zweier verschiedener Trainingsmodalitäten zu Beginn der Therapie mit dem SPT konnte zunächst in beiden Gruppen der bereits bekannte Effekt auf den Schweregrad der POSA und auf die subjektiv empfundene Schläfrigkeit bestätigt werden [27,29]. Ferner zeigte sich in beiden Gruppen eine hohe Therapieadhärenz hinsichtlich der nächtlichen und wöchentlichen Nutzung während des Behandlungszeitraums. Kürzlich wurde von Buyse et al. berichtet, dass über einen 14-tägigen Untersuchungszeitraum 27 von 51 Patienten den SPT nutzten [30]. ...
Article
Background Many patients suffer from positional obstructive sleep apnea (POSA; 56%). In these cases, positional therapy may be an option. A sleep position trainer (SPT) is a small vibrating device that trains the patient to avoid sleeping in the supine position. This study aimed to compare the efficacy and tolerance of gradual and intensive training onset in POSA patients Materials and methods Patients with mild to moderate POSA and incompliance with continuous positive airway pressure (CPAP) therapy were included in this prospective double-blind trail. Patients were randomized according to how training was initiated and the SPT was set to either a gradual or an intensive training program. Polygraphy was used to check respiratory parameters after 1 month, and subjective parameters and compliance were assessed prior to and after this time period using a questionnaire. Results A total of 38 patients were included (20 intensive; 18 gradual; 49 ± 13 years) of whom 31 completed the study protocol. After 1 month the apnea–hypopnea index (AHI) in both groups was significantly reduced, but there was no difference in AHI between the two training modalities (AHI intensive: 16.7 ± 6.3/h to 4.2 ± 3.2/h; AHI gradual: 18.9 ± 11.2/h to 8.4 ± 7.9/h). The same effect was observed for subjective sleepiness. Conclusion The objective severity of OSA and the associated subjective daytime sleepiness was reduced in both groups. There was no difference in terms of clinical outcome or compliance between the gradual or intensive SPT therapy in POSA patients during the observation period. Both training modalities are highly successful and well tolerated.
... Advanced Brain Monitoring, Carlsbad, CA, 2 Sleep Data, San Diego, CA, 3 Sleep Alliance, San Diego, CA Introduction: A previous cross-over study design reported that the combination of oral appliance (OA) and position therapies was more effective than either therapy used individually. 1 This study assessed the distributions of potential outcomes from oral appliance (OA) therapy and/or supine avoidance using a two-night home sleep apnea test (HSAT) and a Trial OA. ...
Conference Paper
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The study characterizes treatment outcome responder phenotypes using oral appliance therapy and/or supine avoidance.
... If the medical sleep study confirms OSA in a dominant supine position, positional therapy, such as a lower back cushion (e.g., Zzoma) or electronic device (e.g., Night Shift or Nightbalance), may be used alone in mild cases or in addition to CPAP or OA (Benoist et al. 2017;de Ruiter et al. 2018;Levendowski et al. 2018). Such cases require the input of a sleep physician. ...
Article
This critical review focuses on obstructive sleep apnea (OSA) and its management from a dental medicine perspective. OSA is characterized by ≥10-s cessation of breathing (apnea) or reduction in airflow (hypopnea) ≥5 times per hour with a drop in oxygen and/or rise in carbon dioxide. It can be associated with sleepiness and fatigue, impaired mood and cognition, cardiometabolic complications, and risk for transportation and work accidents. Although sleep apnea is diagnosed by a sleep physician, its management is interdisciplinary. The dentist’s role includes 1) screening patients for OSA risk factors (e.g., retrognathia, high arched palate, enlarged tonsils or tongue, enlarged tori, high Mallampati score, poor sleep, supine sleep position, obesity, hypertension, morning headache or orofacial pain, bruxism); 2) referring to an appropriate health professional as indicated; and 3) providing oral appliance therapy followed by regular dental and sleep medical follow-up. In addition to the device features and provider expertise, anatomic, behavioral, demographic, and neurophysiologic characteristics can influence oral appliance effectiveness in managing OSA. Therefore, OSA treatment should be tailored to each patient individually. This review highlights some of the putative action mechanisms related to oral appliance effectiveness and proposes future research directions.
... 16 In another two studies using the Nightbalance SPT by Benoist et al, treatment adherence (defined as >4 hours device use/day at least 5 days in a week) was found to be 89.3% 22 and 89.0%, 23 respectively at 3 months. The much lower PT adherence rate seen in our Asian study population reinforces the importance of replicating positive results from Caucasian studies in other ethnic populations. ...
Article
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Objectives: Up to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment. Methods: In this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI≥2 × non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1 week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512). Results: 40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device. Conclusions: The non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.
... Schulter-, Hüft-oder Rückenbeschwerden sowie ein störendes Schnarchen in Seitenlage sollten unter diesem Aspekt vor der Einleitung der Therapie erfragt werden. Aktive Verfahren sind der PAP-Therapie und der Unterkieferprotrusionsschiene (UPS) in ihrer klinischen Wirksamkeit bei leichtbis mittelgradiger OSA ebenbürtig [16,17], obgleich der AHI mit der PAP-Therapie im Mittel stärker gesenkt wird [15]. Es existiert eine Studie mit Smartphone-Apps zur aktiven Lagetherapie, die auf eine vergleichbare Wirkung hinweist [18]. ...
Article
In Germany about one third of adults aged between 30 and 69 years suffer from obstructive sleep apnea (OSA). Snoring, inspiratory flow limitations, hypopneas, and apneas occur, leading to disturbed sleep, reduced daytime performance, and increased cardiovascular morbidity and mortality. Positive airway pressure therapy (PAP therapy) can be successfully administered in every OSA severity. However, other conservative treatments have to be considered for some patients, particularly in PAP failure or intolerance. The individual treatment concept is based on poly(somno)graphic, morphological, and functional assessment, taking treatment acceptance, adherence, and compliance into account.
... Positional obstructive sleep apnea is common, with studies suggesting that 56% of individuals with OSA have POSA, with an additional 30% having a greater supine vs nonsupine AHI without meeting the threshold of being at least twice as great. [1][2][3] The presence of positional changes has implications for treatment selection and outcomes. First, POSA may be treated with positional therapy, either alone or in combination therapy. ...
Article
Importance The anatomic mechanisms underlying positional vs nonpositional obstructive sleep apnea (OSA) are poorly understood and may inform treatment decisions. Objective To examine drug-induced sleep endoscopy (DISE) findings in the supine vs nonsupine body positions in positional and nonpositional obstructive sleep apnea. Design, Setting, and Participants A cross-sectional study of 65 consecutive eligible adults with OSA undergoing DISE without marked tonsillar hypertrophy, including 39 with positional OSA (POSA) and 26 with nonpositional OSA (N-POSA) was conducted in a sleep surgery practice at a tertiary academic medical center. Exposures Drug-induced sleep endoscopy performed in the supine vs nonsupine body position. Main Outcomes and Measures Drug-induced sleep endoscopy findings were scored separately for the supine and lateral body positions using the VOTE classification (velum, oroparyngeal lateral walls, tongue, epiglotis) and with identification of a single primary structure contributing to airway obstruction. Velum-related obstruction was separated into anteroposterior and lateral components. Results The 65 study participants had a mean (SD) age of 52.4 (11.7) years, and 55 (84.6) were men. Mean (SD) body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) was 27.2 (3.1), with only 9 (14%) of 65 participants having a BMI greater than 30. The supine body position was associated with greater odds of anteroposterior velum- (odds ratio [OR], 7.28; 95% CI, 3.53-15.01), tongue- (OR, 29.4; 95% CI, 12.1-71.5), and epiglottis-related (OR, 11.0; 95% CI, 1.3-92.7) obstruction in the entire cohort, with similar findings in the POSA and N-POSA subgroups. The supine body position was associated with a lower odds of oropharyngeal lateral wall–related (OR, 0.22; 95% CI, 0.07-0.70) obstruction in the N-POSA subgroup, whereas there was no increase in the overall sample or the POSA subgroup. The oropharyngeal lateral walls were a common primary structure causing obstruction, especially in the lateral body position. Conclusions and Relevance In a study population of primarily nonobese adults, DISE findings differed based on body position, generally corresponding to gravitational factors. Treatments that address velum- and tongue-related obstruction successfully may be more effective in the POSA population.
... Treatment of OSA is usually initiated with conservative therapies consisting of lifestyle changes, improved sleep hygiene, weight reduction, avoidance of alcohol, and supine sleeping position [6]. After these conservative measures, treatment options include oral appliance therapy (OAT), continuous positive airway pressure (CPAP), and surgery [7][8][9]. ...
Article
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Objective To assess facial esthetics and quality of life (QoL) as measure of success or failure after maxillomandibular advancement (MMA) surgery for obstructive sleep apnea (OSA). Methods Visual analog scales (VAS) on facial esthetics and QoL survey, including EQ-5D3L, Epworth Sleepiness Scale (ESS), and Functional Outcome of Sleep Questionnaire (FOSQ) were collected. Outcomes were analyzed for surgical-success/failure after MMA. Results Forty-one patients returned completed surveys (response: 66%). Mean VAS on facial esthetics was 57 ± 22 mm preoperative and 51 ± 24 mm postoperative (p = 0.217). When MMA was considered a surgical-failure, VAS was significantly more negative (40 ± 22 mm; p = 0.026). EQ-5D-3L showed an overall mean score of 73.2 ± 15.7, ESS was 6.3 ± 5.4, and FOSQ was 16.0 ± 3.3. Conclusion No significant alteration of facial esthetics were reported after MMA; however, lower QoL was associated with surgical-failure; whereas, in surgical-success, QoL were higher.
... OSA is a relevant problem, with a prevalence of 12.5% in men and 5.9% in women, characterized by an apneahypopnea index (AHI) of more than 5 per hour and excessive daytime sleepiness [4]. For mild to moderate OSA, treatment options include oral appliance therapy (OAT), positional therapy (PT), upper airway surgery (UASurg), or a combination of different treatment modalities [5][6][7][8]. The gold standard therapy to treat moderate to severe OSA is continuous positive airway pressure (CPAP). ...
Article
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Purpose To evaluate the effect of different passive maneuvers (lateral head rotation and jaw thrust) during drug-induced sleep endoscopy (DISE) on distribution of collapse patterns at the level of velum, oropharynx, tongue base, and epiglottis (VOTE). Methods Retrospective, single-center cohort study. Patients diagnosed with OSA who underwent DISE between August 2016 and February 2017 were included. During DISE procedure lateral head rotation, jaw thrust and a combination of both were applied and scored by VOTE obstruction level. Also, the effect of these maneuvers was analyzed for complete concentric collapse (CCC) versus complete non-concentric collapse (CNCC) subgroups. Results Two hundred patients were included (161 male (80.5%), mean age 50.1 ± 11.7 years, median AHI 19.2 (11.7, 31.0) events/h). For lateral head rotation, significant improvement in upper airway collapse at all levels was observed, with exception of the level of the oropharynx, where an increase in obstruction was seen. Jaw thrust resulted in a significant decrease of collapse on all four VOTE levels. The CCC group responded similarly to the CNCC group when only one maneuver was applied, but the CCC group showed less improvement when both maneuvers were combined. Conclusions This study gives new insights into the changes in distribution of collapse patterns when passive maneuvers are applied during DISE. Jaw thrust and lateral head rotation gave improvement of obstruction mostly in line with previous research. The CNCC and CCC groups responded similarly to application of a single maneuver, but there was a significant difference found when both maneuvers were combined.
... Table S1 reports the data extracted from the included studies, and [49][50][51][52][53] another investigation compared a titratable DB MAD with a non-titratable DB MAD, 54 one study compared the efficacy of the same DB MAD with and without vertical elastic bands, 55 2 studies compared a DB customised MAD with a non-customised MAD 56,57 and 3 studies compared DB MADs with other therapies like a tongue retaining device 58 and the positional therapy. 59,60 Three studies compared different mandibular advancement degrees of a MB MAD, 61-63 2 studies compared a MB MAD with ENT surgery, 64,65 one study compared a customised with a non-customised MB MAD 62 and 4 studies compared a MB MAD with placebo. [66][67][68][69][70] The follow-up period varied among the studies included from 2 weeks to about 4 years. ...
Article
Background Mandibular advancement devices (MADs) are used to treat patients with obstructive sleep apnea (OSA). To date, there are no data that identify the most effective MAD design for apnea‐hypopnea index (AHI) reduction. Objectives The purpose of this systematic review is to investigate the effectiveness of different MAD designs in AHI reduction and oxygen saturation improvement in OSA patients. Search Methods An electronic search was performed in MEDLINE, Cochrane Database, Scopus, Web of Knowledge and LILACS. Selection Criteria Randomized controlled trials (RCTs) investigating the reduction of AHI on adult patients wearing MAD for OSA were included. Data Collection and Analysis the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and the risk of bias by the Cochrane Collaboration’s tool for assessing risk of bias in randomized controlled trial. The success rate of each study was computed: [(mean baseline AHI–mean AHI after treatment)/mean baseline AHI]. Results fifty RCTs were included. The risk of bias resulted with some concerns in most of the studies. The GRADE scores indicated that the quality of evidence was very low. The meta‐analysis showed a success rate with mono‐bloc and duo‐bloc MADs respectively of 0.821[0.722‐0.887] and 0.547[0.443‐0.637]. The mono‐bloc compared with duo‐bloc better improved the minimum oxygen saturation (10.048[7.733‐12.363] and 3.357[2.290‐4.423] respectively). Conclusions there is a very low quality body of evidence that mono‐bloc MADs are more effective in reducing AHI and improving minimum oxygen saturation compared with duo‐bloc MADs. Registration: the study protocol was registered on PROSPERO (n. CRD42019118084).
... In einer weiteren randomisierten Studie war die aktive Lagetherapie der Therapie mit einer UPS bei lagebabhängiger OSA ebenbürtig [53], und in einer weiteren Studie zeigte sich die Kombination beider Therapien signifikant wirksamer als die einzelnen Therapien [54]. ...
... In einer weiteren randomisierten Studie war die aktive Lagetherapie der Therapie mit einer UPS bei lagebabhängiger OSA ebenbürtig [53], und in einer weiteren Studie zeigte sich die Kombination beider Therapien signifikant wirksamer als die einzelnen Therapien [54]. ...
... Many devices for positional therapy are in the shape of a chest-worn band, which was developed under the same principle as TBT [108][109][110]. In addition, new technologically advanced devices have been developed in recent years [111][112][113][114][115]. While these effects have also been verified by randomized crossover studies and randomized controlled trials, most are small-scale. ...
Article
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The prevalence of sleep-disordered breathing (SDB) is reportedly very high. Among SDBs, the incidence of obstructive sleep apnea (OSA) is higher than previously believed, with patients having moderate-to-severe OSA accounting for approximately 20% of adult males and 10% of postmenopausal women not only in Western countries but also in Eastern countries, including Japan. Since 1998, when health insurance coverage became available, the number of patients using continuous positive airway pressure (CPAP) therapy for sleep apnea has increased sharply, with the number of patients about to exceed 500,000 in Japan. Although the “Guidelines for Diagnosis and Treatment of Sleep Apnea Syndrome (SAS) in Adults” was published in 2005, a new guideline was prepared to indicate the standard medical care based on the latest trends, as supervised by and in cooperation with the Japanese Respiratory Society and the “Survey and Research on Refractory Respiratory Diseases and Pulmonary Hypertension” Group, of Ministry of Health, Labor and Welfare and other related academic societies, including the Japanese Society of Sleep Research, in addition to referring to the previous guidelines. Since sleep apnea is an interdisciplinary field covering many areas, this guideline was prepared including 36 clinical questions (CQs). In the English version, therapies and managements for SAS, which were written from CQ16 to 36, were shown. The Japanese version was published in July 2020 and permitted as well as published as one of the Medical Information Network Distribution Service (Minds) clinical practice guidelines in Japan in July 2021.
... It has been shown to be a well-tolerated treatment modality reducing respiratory parameters and subjective sleepiness assessed by the Epworth Sleepiness Scale (ESS) and improving sleeprelated quality of life without negatively affecting sleep efficiency (van Maanen et al. 2013; van Maanen and de Vries 2014). In a randomized trial comparing SPT to mandibular advancement device (MAD) it was found that both treatment options were equally effective in reducing AHI values in patients with mild to moderate POSA (Benoist, de Ruiter, et al. 2017). PT can be used as a standalone treatment or as part of a multimodality therapeutic approach. ...
... Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder that is associated with both short and long-term adverse health consequences (Devulapally et al., 2009;Punjabi et al., 2009;Young et al., 2002). Whole body (i.e., torso) posture during sleep is commonly measured due to its contribution to OSA severity in 25% to 60% of patients (Joosten et al., 2014;Oksenberg, 1997), and postural therapy has been a long recognized treatment alternative to continuous positive airway pressure (CPAP) for selected patients (Benoist et al., 2017;Cartwright et al., 1985). However, postural therapies only focus on positioning the torso in a lateral rather than supine position, and it remains unclear whether flexion/extension and/or rotation of the head relative to the torso also influence OSA severity. ...
Article
Head posture influences the collapsibility of the passive upper airway during anaesthesia. However, little is known about the impact of head posture during sleep. The objective of this study was to develop and validate an instrument to measure head posture during supine sleep and to apply this instrument to investigate the influence of head posture on obstructive sleep apnea (OSA) severity. A customized instrument to quantify head flexion and rotation during supine sleep was developed and validated in a benchtop experiment. Twenty‐eight participants with suspected OSA were successfully studied using diagnostic polysomnography with the addition of the customized instrument. Head posture in supine sleep was discretized into four categories by two variables: head flexed or not (flexion >15°); and head rotated or not (rotation >45°). Sleep time in each posture and the posture‐specific apnea–hypopnea index (AHI) were quantified. Linear mixed‐effect modelling was applied to determine the influence of flexion and rotation on supine OSA severity. Twenty‐four participants had ≥15 min of supine sleep in at least one head‐posture category. Only one participant had ≥15 min of supine sleep time with the head extended. Head flexion was associated with a 12.9 events/h increase in the AHI (95% CI: 3.7–22.1, p = .007). Head rotation was associated with an 11.0 events/h decrease in the AHI (95% CI: 0.3–21.6, p = .04). Despite substantial interparticipant variability, head flexion worsened OSA severity, and head rotation improved OSA severity. Interventions to promote rotation and restrict flexion may have therapeutic benefit in selected patients.
... The primary analysis was unadjusted, but a secondary analysis was adjusted for age and sex, but not other variables due to the relatively small number of patients. Another secondary analysis ("Per protocol analysis," 32,33 MDA was calculated by two methods: MDA p using AHI on treatment obtained from end of study PSG and MDA c calculated using AHI on treatment obtained from 6-month CPAP download. MDA c was only calculated for the treatment group since for the sham CPAP group, there was no AHI obtainable from download. ...
Article
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Objective: The aim of this study was to evaluate the effect of continuous positive airway pressure (CPAP) treatment on the Fatigue Severity Scale (FSS, preplanned primary outcome), another fatigue measure, sleep quality, somnolence, pain, disability, and quality of life in multiple sclerosis (MS) patients with obstructive sleep apnea-hypopnea (OSAH). Methods: In a randomized, double-blind trial (NCT01746342), MS patients with fatigue, poor subjective sleep quality, and OSAH (apnea-hypopnea index of ⩾ 15 events per hour/sleep), but without severe OSAH (apnea-hypopnea index > 30, and 4% oxygen desaturation index > 15 events/hour or severe somnolence), were randomized to fixed CPAP or sham CPAP for 6 months. Outcome assessments were performed at 3 and 6 months. Results: Of 49 randomized patients, 34 completed the protocol. Among completers, FSS did not improve with CPAP compared to sham at 6 months. FSS tended to improve (p = 0.09), and sleepiness (Epworth Sleepiness Scale) improved significantly (p = 0.03) at 3 months with CPAP compared to sham, but there were no other improvements with CPAP at either study evaluation. Conclusion: In non-severe OSAH patients, CPAP did not significantly improve the primary outcome of FSS change at 6 months. In secondary analyses, we found a trend to improved FSS, and a significant reduction in somnolence with CPAP at 3 months.
... In another randomized trial, active positional therapy was equivalent to treatment with a mandibular advancement device (MAD) for positional OSA [53], while in yet another study, a combination of the two therapies was shown to be significantly more effective than the individual therapies [54]. ...
... Both modalities are close to mimicking the expected effect on upper-airway obstruction of a MAD, which reduces the AHI by 50% [6]. Head-and-trunk rotation reduced obstruction by 55% and thus mimicked the effect of PT, which reduces the AHI by 54% [20,21]. ...
Article
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PurposeAs drug-induced sleep endoscopy (DISE) can provide additional diagnostic information on collapse patterns of the upper-airway, it is widely used in patients with obstructive sleep apnea (OSA). Although more controversial, DISE may also predict the success of treatment with a mandibular advancement device (MAD) and/or positional therapy (PT). In 2018, we proposed a prediction model to investigate the predictive value of passive maneuvers during DISE — such as jaw thrust and changes in body position — on upper-airway patency. Based on the outcomes of various studies, we then adjusted our DISE protocol to better mimic the effect of a MAD, PT, or a combination of both. The aim of this study was to verify whether or not our adjustments would increase the value of DISE as a selection tool.Methods This single-center retrospective cohort study involved a consecutive series of patients with OSA. Patients were included if a DISE had been performed in supine and non-supine sleeping position and with and without a boil-and-bite MAD in situ between December 2018 and February 2020. The VOTE scoring system was used to evaluate the obstruction at four levels of the upper-airway.ResultsAmong 94 patients included. the median apnea–hypopnea index (AHI) was 16.2 (events/h). As a temporary MAD during DISE reduced obstruction by 54% and jaw thrust by 57%, both mimicked the effect of the custom-made MADs referred to in the literature, which reduces the AHI by 60%. Head-and-trunk rotation reduced obstruction by 55% and thus mimicked the effect of PT, which is known to reduce the AHI by 50%.ConclusionA jaw thrust, a temporary MAD, and head-and-trunk rotation during DISE all seem to mimic the treatment effects of MAD and PT. These findings may be of added value when choosing OSA treatment. To prove the predictive value of these maneuvers during DISE, a prospective study should be performed.
Article
Objectives: Last years, vibrating devices were introduced to treat positional sleep apnoea (POSA). However, few data exist on determinants of effectiveness and adherence in clinical settings. Methods: The NightBalance Sleep Position Trainer (SPT) analyses the patient's position during the first 2 nights, starts to build up vibrations during the following 7 and is 100% performant from night 10 on; and, reports on %supine, usage time, number of (responses on) vibrations. The device was started for a 28-day try-out period in a clinical cohort of 51 consecutive patients with POSA. SPT-stored data were studied on different time points: first 2 nights without vibrations (baseline), first 2 nights on SPT 100% performance (short term) and 2 later nights after having used the full performant device for 14 days (long term). Results: Only 27 patients used the device throughout the long-term period. The baseline %supine was lower than during polysomnography: 22.9 ± 16.2 versus 40.7 ± 20.0% (p = 0.0005). Apnoea-hypopnoea index calculation taking into account the %supine on SPT revealed that 2/27 patients would not have obstructive sleep apnoea at home. The baseline %supine dropped (p < 0.0001) on short term without further change on long term. Ten patients could be considered cured and demonstrated higher response on vibrations. Only 29 patients could be considered as adherent, and they demonstrated higher response on vibrations and less side effects; only 13 wanted to purchase the SPT. Conclusion: On polysomnography, the %supine is overestimated. The efficacy and low adherence are influenced by differences in response to vibrations. The training effect is already presented on short term.
Chapter
Health-related quality of life (HRQoL) refers to the impact of health on a person's quality of life and sense of well-being. Sleep is recognized as an essential component of health. Accordingly, sleep disorders can significantly influence HRQoL. Obstructive sleep apnea (OSA) is a prevalent sleep disorder that diminishes HRQoL on both generic and disease-specific HRQoL questionnaires. Both types of HRQoL instruments are useful in OSA, as they provide complementary information. In the ever-changing landscape of OSA treatment, the patient voice, captured by HRQoL tools, will be critical in directing healthcare resources toward the most efficacious and patient-centered therapies.
Research
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Article
Positional therapy appears to be an attractive strategy for many patients with positional obstructive sleep apnea (OSA). However, under the American Academy of Sleep Medicine OSA guidelines, positional therapy is considered as only an alternative therapy, because previous research has demonstrated poor treatment tolerance and adherence. Recent technological advances have renewed interest in positional therapy, with the invention of new sophisticated vibratory positional therapy devices. These devices have shown great promise with efficacy, markedly improved patient tolerance, and long-term adherence. We review the literature on positional therapy and explore the most current evidence on the new positional therapy devices.
Article
Background: The modalities of therapy for obstructive sleep apnoea (OSA) include behavioural and lifestyle modifications, positional therapy, oral appliances, surgery and continuous positive airway pressure therapy (CPAP). Though CPAP has proven efficacy in treating OSA, adherence with CPAP therapy is suboptimal. Positional therapy (to keep people sleeping on their side) is less invasive and therefore expected to have better adherence. This review considered the efficacy of positional therapy compared to CPAP as well as positional therapy against no positional therapy. Devices designed for positional therapy include lumbar or abdominal binders, semi-rigid backpacks, full-length pillows, a tennis ball attached to the back of nightwear, and electrical sensors with alarms that indicate change in position. Objectives: To compare the efficacy of positional therapy versus CPAP and positional therapy versus inactive control (sham intervention or no positional therapy intervention) in people with OSA. Search methods: We identified studies from the Cochrane Airways' Specialised Register (including CENTRAL, MEDLINE, Embase, CINAHL, AHMED and PsycINFO), ClinicalTrials.gov, and the World Health Organization trials portal (ICTRP). It also contains results derived from handsearching of respiratory journals and abstract books of major annual meetings. We searched all databases from their inception to September 2018, with no restrictions on language of publication or publication type. Selection criteria: We included randomised controlled trials comparing positional therapy with CPAP and positional therapy with inactive control. Data collection and analysis: Two review authors independently selected studies and extracted the data. We used a random-effects model in the meta-analysis to estimate mean differences and confidence intervals. We assessed certainty of evidence using the GRADE approach. Main results: We included eight studies. The studies randomised 323 participants into two types of interventions. The comparison between positional therapy and CPAP included 72 participants, while the comparison between positional therapy and inactive control included 251 participants. Three studies used supine vibration alarm devices, while five studies used physical positioning like specially designed pillows or semirigid backpacks.Positional therapy versus CPAPThe three studies included for this comparison were randomised cross-over trials. Two studies found that there was no difference in Epworth Sleepiness Scale (ESS) scores between CPAP and positional therapy. Two studies showed that CPAP produced a greater reduction in Apnoea-Hypopnoea Index (AHI) with a mean difference (MD) of 6.4 events per hour (95% CI 3.00 to 9.79; low-certainty evidence) compared to positional therapy. Subjective adherence, evaluated in one study, was found to be significantly greater with positional therapy (MD 2.5 hours per night, 95% CI 1.41 to 3.59; moderate-certainty evidence).In terms of secondary outcomes, one study each reported quality-of-life indices and quality-of-sleep indices with no significant difference between the two groups. One study reported cognitive outcomes using multiple parameters and found no difference between the groups. There were insufficient data to comment on other secondary outcomes like respiratory disturbance index (RDI), and frequency and duration of nocturnal desaturation. None of the studies clearly reported adverse effects.Positional therapy versus inactive controlThree studies of positional therapy versus no intervention were randomised cross-over trials, while two studies were parallel-arm studies. Data from two studies showed that positional therapy significantly improved ESS scores (MD -1.58, 95% CI -2.89 to -0.29; moderate-certainty evidence). Positional therapy showed a reduction in AHI compared with control (MD -7.38 events per hour, 95% CI -10.06 to -4.7; low-certainty evidence). One study reported adherence. The number of participants who continued to use the device at two months was no different between the two groups (odds ratio (OR) 0.80, 95% CI 0.33 to 1.94; low-certainty evidence). The same study reported adverse effects, the most common being pain in the back and chest, and sleep disturbance but there was no significant difference between the two groups in terms of device discontinuation (OR 1.25, 95% CI 0.5 to 3.03; low-certainty evidence). One study each reported quality-of-life indices and quality-of-sleep indices, with no significant difference between the two groups. One study reported cognitive outcome, and found no difference between the groups. There was insufficient evidence to comment on other secondary outcomes (RDI, frequency and duration of nocturnal desaturation). Authors' conclusions: The review found that CPAP has a greater effect on improving AHI compared with positional therapy in positional OSA, while positional therapy was better than inactive control for improving ESS and AHI. Positional therapy may have better adherence than CPAP. There were no significant differences for other clinically relevant outcomes such as quality of life or cognitive function. All the studies were of short duration. We are unable to comment on the long-term effects of the therapies. This is important, as most of the quality-of-life outcomes will be evident only when the therapies are given over a longer period of time. The certainty of evidence was low to moderate.
Article
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Obstructive sleep apnoea Obstructive sleep apnoea (OSA) is a complex condition with many different phenotypes. Historically, OSA has been defined using the apnoea-hypopnoea index (AHI). However, because there is no clear relationship between the AHI and the severity of symptoms and comorbidities the degree of hypoxia is increasingly being used to define OSA severity. To reach a diagnosis of obstructive sleep apnoea syndrome (OSAS), it has to be shown that symptoms improve with therapy. The treatment of first choice for patients with severe OSA is continuous positive airway pressure (CPAP) therapy. The indication for other therapies depends upon the patient's characteristics and preferences. Treatment with a position trainer and implantation of a hypoglossal nerve stimulator are relatively new therapies. OSA is a cardiovascular risk factor, but the effect of OSA treatment on cardiovascular outcome measures and mortality has not been shown in clinical trials.
Chapter
Obstructive sleep apnea (OSA) treatment is primarily focused on the usage of positive airway pressure (PAP) to stent open the upper airway to prevent obstruction and subsequent oxyhemoglobin desaturation. Unfortunately, the success rate of individuals on PAP therapy is mixed. Given this challenge, adjunctive and alternative measures need to be understood and offered to patients to ensure adequate relief of their symptoms, such as daytime sleepiness, and to prevent long term complications. In this chapter, we aim to discuss a variety of adjunctive and alternative treatment options for the treatment of OSA and these will be discussed in two broad categories: non-surgical and surgical treatments.
Chapter
Oral appliances (OAs) aim to increase the upper airway size, facilitate breathing during the night, and reduce obstructive sleep apnea (OSA) and snoring (◘ Fig. 13.1a, b). There are two subgroups of OAs: the mandibular advancement device (OAM) (◘ Fig. 13.2) and the tongue-retaining device (OAT) (◘ Fig. 13.3). OAM is attached to the teeth and holds the mandible forward during sleep. This treatment has the highest level of evidence among non-PAP therapies [1–4]. OAT aims to hold the tongue forward into an anterior bulb by suction and can be used irrespective of the presence of teeth. Both devices reduce sleep apneas, but OAM is better tolerated and has been much more studied.
Article
Study objectives: Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h. Methods: This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study. Results: A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h, P < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes, P < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective. Conclusions: Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group. Clinical trial registration: Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.
Chapter
In dit hoofdstuk wordt achtereenvolgens aandacht besteed aan verschillende slaapgerelateerde ademhalingsstoornissen (obstructief slaapapneusyndroom, centraal slaapapneusyndroom en obesitas-hypoventilatiesyndroom), hun prevalenties, gevolgen, comorbiditeit (in het bijzonder psychiatrische stoornissen) en mogelijke behandelingen. Slaapgerelateerde ademhalingsstoornissen zijn, na insomnie, de meest voorkomende groep slaapstoornissen. Er zijn aanwijzingen dat de prevalentie nog hoger is bij mensen met een ernstige psychiatrische aandoening. Echter, in tegenstelling tot bij insomnie, is er tot nu toe weinig wetenschappelijk onderzoek gedaan naar de wisselwerking tussen slaapapneu en psychiatrische stoornissen. Er is enige evidentie dat slaapapneu het risico op een depressie vergroot en psychiatrische symptomen kan verergeren. Omdat de kennis over mogelijke interacties nog zo beperkt is, wordt geadviseerd zowel de slaapgerelateerde ademhalingsstoornis als de psychiatrische aandoening te behandelen.
Article
The prevalence of sleep disordered breathing (SDB) is reportedly very high. Among SDBs, the incidence of obstructive sleep apnea (OSA) is higher than previously believed, with patients having moderate-to-severe OSA accounting for approximately 20% of adult males and 10% of postmenopausal women not only in Western countries but also in Eastern countries, including Japan. Since 1998, when health insurance coverage became available, the number of patients using continuous positive airway pressure (CPAP) therapy for sleep apnea has increased sharply, with the number of patients about to exceed 500,000 in Japan. Although the “Guidelines for Diagnosis and Treatment of Sleep Apnea Syndrome (SAS) in Adults” was published in 2005, a new guideline was prepared in order to indicate the standard medical care based on the latest trends, as supervised by and in cooperation with the Japanese Respiratory Society and the “Survey and Research on Refractory Respiratory Diseases and Pulmonary Hypertension” Group, of Ministry of Health, Labor and Welfare and other related academic societies, including the Japanese Society of Sleep Research, in addition to referring to the previous guidelines. Because sleep apnea is an interdisciplinary field covering many areas, this guideline was prepared including 36 clinical questions (CQs). In the English version, therapies and managements for SAS, which were written from CQ16 to 36, were shown. The Japanese version was published in July 2020 and permitted as well as published as one of the Medical Information Network Distribution Service (Minds) clinical practice guidelines in Japan in July 2021.
Article
Background mandibular advancement devices (MADs) are used as an alternative to continuous positive airways pressure to treat obstructive sleep apnea (OSA) patients, but to date specific data on the adherence to MAD therapy are lacking. Objectives the aim of the present systematic review is to investigate the dropout rate and adherence of OSA patients to different custom-made (CM) and non-custom-made (NCM) MAD therapies. Search Methods an electronic search was performed in MEDLINE, Cochrane Database of Systematic Reviews, Scopus, LILACS and Web of Science. Selection Criteria randomized controlled trials (RCTs) assessing the compliance to customized and not customized MADs in the treatment of adult OSA patients were included. Data collection and analysis the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and the risk of bias by the Cochrane Collaboration’s tool for assessing risk of bias in RCT. The dropout rate of each study was computed and the adherence to MAD therapy in terms of hours per night and nights per week was extracted from each study. Results thirty-two RCTs were included. The risk of bias resulted low in most of the studies. The GRADE scores indicated that the quality of evidence was from very low to moderate. The meta-analyses showed that mean dropout rate did not significantly differ between CM and NCM MADs: the overall mean dropout rate was 0.171[0.128-0.213] with a mean follow-up of 4.1 months. The hours per night adherence was significantly higher for CM MADs (6.418[6.033-6.803]) compared to NCM MADs (5.107[4.324-5.890]. The meta-regression showed that the dropout rate increases significantly during time (p<0.05). Conclusions There is a very low to moderate quality of evidence that the dropout rate of MAD therapy is similar among CM and NCM MADs, that the dropout rate increases significantly during time and that CM MADs have higher hours per night adherence compared with NCM MAD.
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Positional therapy appears to be an attractive strategy for many patients with positional obstructive sleep apnea (OSA). However, under the American Academy of Sleep Medicine OSA guidelines, positional therapy is considered as only an alternative therapy, because previous research has demonstrated poor treatment tolerance and adherence. Recent technological advances have renewed interest in positional therapy, with the invention of new sophisticated vibratory positional therapy devices. These devices have shown great promise with efficacy, markedly improved patient tolerance, and long-term adherence. We review the literature on positional therapy and explore the most current evidence on the new positional therapy devices.
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Obstructive sleep apnea (OSA) telehealth management may improve initial and chronic care access, time to diagnosis and treatment, between-visit care, e-communications and e-education, workflows, costs, and therapy outcomes. OSA telehealth options may be used to replace or supplement none, some, or all steps in the evaluation, testing, treatments, and management of OSA. All telehealth steps must adhere to OSA guidelines. OSA telehealth may be adapted for continuous positive airway pressure (CPAP) and non-CPAP treatments. E-data collection enhances uses for individual and group analytics, phenotyping, testing and treatment selections, high-risk identification and targeted support, and comparative and multispecialty therapy studies.
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There has been a recent surge in the number of potential alternative therapies that have been proposed and marketed for adults with OSA. This Perspective finds that many of these alternatives do not have high-quality studies showing clear benefits. Health care providers must treat adults with OSA using treatments either supported by high-quality, peer-reviewed publications showing benefit or as part of ongoing rigorous clinical trials.
Article
Rationale: Approximately 60% of the patients with obstructive sleep apnoea suffer from a positional effect, and approximately 25% of these patients present events only in the supine position. Objective: To validate a new positional vibrating device and evaluate its efficacy in reducing the Apnoea-Hypopnoea Index and the total sleep time in the supine position without disturbing sleep. Methods: A total of 128 patients were recruited for this multicentre, prospective, parallel, randomised controlled trial and were distributed in three arms (general recommendations, inactive and active device). Full overnight polysomnography was performed at baseline and at 12 weeks. Anthropometric variables and sleep and quality of life questionnaires were collected at 4, 8 and 12 weeks. Results: The Apnoea-Hypopnoea Index decreased from 30.6 per hour to 20.4 per hour (p<0.001) in the active device (AD) group. In this group the reduction was 2.3-fold and 3.3-fold than the ones in the general recommendations (GR) and inactive device (ID) groups, respectively (p=0.014). Sleep time in supine position decreased 17.7%±26.3% in GR group (p<0.001), 13.0%±22.4% with ID group (p<0.001) and 21.0%±25.6% in the AD group (p<0.001). Furthermore, total sleep time increased significantly only in the AD group (22.1±57.5 min, p=0.016), with an increased percentage of time in the N3 (deep sleep) and N3+REM (rapid eye movement) stages, without sleep fragmentation. Conclusion: The device was effective in reducing the Apnoea-Hypopnoea Index and time spent in the supine position also in improving sleep architecture. Therefore, the device could be a good option for the management of patients with positional obstructive sleep apnoea. Trial registration details: The trial was registered at www.clinicaltrials.gov (NCT03336515).
Article
In Germany about one third of adults aged between 30 and 69 years suffer from obstructive sleep apnea (OSA). Snoring, inspiratory flow limitations, hypopneas, and apneas occur, leading to disturbed sleep, reduced daytime performance, and increased cardiovascular morbidity and mortality. Positive airway pressure therapy (PAP therapy) can be successfully administered in every OSA severity. However, other conservative treatments have to be considered for some patients, particularly in PAP failure or intolerance. The individual treatment concept is based on poly(somno)graphic, morphological, and functional assessment, taking treatment acceptance, adherence, and compliance into account.
Article
Objective This scoping review aims to describe dental treatment-related patient-reported outcomes (dPROs) while using oral appliances (OAs) to manage obstructive sleep apnea (OSA) in children and adults. Study selection Available literature that assessed dPROs in children and adults with OSA managed through OAs. Any clinical studies were included without restrictions of year or country. The results were analyzed and reported using narrative text and tables accompanying a descriptive summary. Results The searches identified 1718 citations, and of these, forty-five studies were finally included. A total of 3,498 adults were included in all 42 primary studies included in this review, in which all the studies presented adults as participants. The dPROs assessed were quality of life (QoL), reported side effects after OA usage, patient satisfaction and experience with treatment, and subjective perception of occlusal changes after treatment. Conclusion This scoping review suggests that dPROs are mostly investigated as a secondary outcome from major studies exploring the effects of OAs on OSA severity, and often, dPROs are not well discussed or displayed on their report. As no risk of bias or certainty level assessment was completed, findings need to be carefully considered. Although in general terms management with OAs among adults with OSA does not seem to be uncomfortable or causing major problems to their lives, some mild discomfort and endured occlusal disturbances was reported in some studies. QoL seems to improve but consistent agreement was elusive. Data does not include experiences among those that dropped OA use. No data seems to exist about PROs in children.
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Background Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain. Methods After a 1-week run-in period during which the participants used sham CPAP, we randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. Secondary end points included other cardiovascular outcomes, health-related quality of life, snoring symptoms, daytime sleepiness, and mood. Results Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea–hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% confidence interval, 0.91 to 1.32; P=0.34). No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood. Conclusions Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease. (Funded by the National Health and Medical Research Council of Australia and others; SAVE ClinicalTrials.gov number, NCT00738179; Australian New Zealand Clinical Trials Registry number, ACTRN12608000409370.)
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Purpose/backgroundA considerable portion of patients has residual positional obstructive sleep apnea (POSA) after upper airway surgery. Those patients could benefit from additional treatment with positional therapy (PT). The objective of this prospective study was to assess the additional effect of PT in patients with residual POSA after upper airway surgery for sleep apnea. MethodsA polysomnography (PSG) was used to diagnose a patient with residual POSA after surgery. After informed consent, patients were treated with PT for 3 months and underwent a follow-up PSG while using the sleep position trainer (SPT). Changes in apnea-hypopnea index (AHI) and sleep position parameters were analyzed. Compliance rates and mean disease alleviation (MDA) were determined. ResultsThirty-three patients with a median postoperative AHI of 18.3/h sleep were included. With the SPT median AHI dropped to 12.5/h sleep and the Epworth Sleepiness Scale (ESS) improved from 10.0 to 7.0. After 3 months, 37.5 % patients were considered responders of whom 31.3 % had treatment success. The compliance rate with SPT was 89.0 %. MDA was 44.7 % for SPT alone. With the combination of both surgery and SPT, MDA was 65.6 %. Conclusions The results of this study indicate that additional PT in a complex OSA patient population with residual POSA after surgery can increase overall therapeutic effectiveness by improving the median MDA from 39.5 % (effect of surgery alone) to 65.6 % (effect of combining surgery and PT).
Article
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Importance: The main reported reasons for discontinuation of oral appliance therapy for sleep-related disordered breathing (SDB) are the presence of self-perceived adverse effects and self-appreciated lack of efficacy. However, these conclusions rely only on subjective compliance data. Objective: To determine which parameters are correlated with objectively measured data on compliance with oral appliance therapy. Design, setting, and participants: For 51 outpatients with SDB, a prospective clinical trial using oral appliance therapy was conducted at Antwerp University Hospital from February 7, 2011, to October 8, 2013 (38 [75%] males; mean [SD] age, 49.3 [9.0] years; mean [SD] apnea-hypopnea index, 14.9 [9.3] events per hour of sleep; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 26.3 [2.8]). Analysis was performed November 5, 2014. Intervention: Oral appliance therapy with a custom-made, titratrable mandibular advancement device (OAm). Main outcomes and measures: Possible correlations were assessed between objective compliance and patients' anthropometric characteristics, polysomnographic parameters, and answers to 3 subjective questionnaires (the visual analog scale for snoring, the Epworth Sleepiness Scale, and an adverse effects questionnaire). Results: Median oral appliance use was 6.4 hours per night (range, 4.7-7.2 hours per night) at the 3-month follow-up. None of the anthropometric and polysomnographic parameters were correlated with compliance. No correlation was found between objective compliance and reports of excessive daytime sleepiness. However, a significant inverse correlation was found between objective compliance and posttreatment visual analog scale values for snoring (P = .006; ρ = -0.40). In addition, objective compliance was correlated significantly with a more pronounced decrease in socially disturbing snoring (P = .005; ρ = 0.39). The presence of dry mouth was the only adverse effect that was negatively correlated with objective compliance at the 3-month follow-up (P < .05; ρ = -0.31). Conclusions and relevance: Neither the anthropometric and polysomnographic parameters nor reports of excessive daytime sleepiness correlated with compliance during oral appliance therapy. The 2 parameters that were correlated with higher objective compliance during oral appliance therapy were a more pronounced decrease in snoring and the presence of dry mouth during treatment. Trial registration: clinicaltrials.gov Identifiers: NCT01284881 and NCT01532050.
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EDITORIALS O bstructive sleep apnea (OSA) is a highly prevalent disease with a complex pathophysiology. 1,2 When undiagnosed or untreated OSA leads to subsequent morbidity and significant long-term mortality, also in patients with mild to moderate disease. 3 Treatment with continuous positive airway pressure (CPAP) and oral appliance therapy with mandibular advance-ment devices (OAm) are the two treatments for OSA whose effects on cardiovascular endpoints have been assessed in randomized controlled trials (RCT). 4–7 However, both thera-peutic options have their possible limitations as CPAP treatment often comes with low patients' acceptance, poor tolerance and suboptimal compliance, whereas OAm therapy generally has an inferior efficacy as compared to CPAP. 4,8–10 Indeed, according to the mean disease alleviation (MDA) concept, the risk that the greater efficacy of CPAP is being offset by its inferior compli-ance relative to OAm therapy is not imaginary, resulting in a similar overall effectiveness for both therapeutic modalities. 4,9 In other words, treatment of OSA with CPAP, OAm or other non-CPAP modalities, as a single treatment, will commonly be associated with an incomplete elimination of the disease with mean values of the MDA index, as a marker of real clinical effec-tiveness, ranging from 40 to 59 %. 8,11,12 Supporting data from the literature on the role and impact of adjunct therapy that can be used as needed in order to improve the MDA index of the primary treatment options are scarce. 13 Case series have been published on the combination of CPAP with OAm therapy for the treatment of OSA. 14,15 It has been demonstrated that when mandibular protrusion is limited in case of OAm therapy, a combined approach utilizing both mandibular protrusion and tongue retention is able to provide an effective treatment for moderate-to-severe OSA as the addi-tion of a tongue bulb to the OAm provides further therapeutic effectiveness. 16 Furthermore, adjunct OAm therapy has been shown to be an effective mode of combination therapy to control OSA after failure of upper airway surgery. 2,17 Multilevel surgery, being the combination of more than one surgical technique, can also be considered as combination therapy for OSA. 18–23 In obese patients with severe OSA, CPAP requirements might be decreased after bariatric surgery and these lower CPAP pres-sures may yet lead to an increased CPAP tolerance and an improved overall compliance with CPAP. 23 The effectiveness of other conceivable and convenient combinations in specific patients needs to be put into perspective and requires further investigation in ongoing studies or future trials. Interestingly, in addition, at least half of OSA patients are reported to suffer from supine-dependent or positional OSA (POSA), commonly defined as an apnea/hypopnea-index (AHI) being at least twice as high in the supine sleeping position as compared to the AHI in the non-supine positions. 24,25 While newer methods to treat POSA with higher compliance rates are emerging, the relevance of this finding of POSA being that common is highly relevant. 26–28 Recently, it has been reported that about 1 out of 3 patients still suffer from residual POSA while undergoing OAm therapy. 29 The results of a recently published RCT indicate that in these patients with residual POSA under OAm therapy the combination of OAm and a sleep position trainer leads to a significant improvement of the therapeutic effectiveness with an increase of the MDA index changing from 42% with OAm alone to 70% with the combina-tion treatment of OAm and sleep position trainer, respectively. 30 Similarly, positional treatment might also be an adjunct treat-ment in patients on CPAP who require higher pressure levels in the supine sleeping position than in the non-supine positions in order to improve CPAP compliance. 31 From a theoretical and conceptual perspective, the combination of positional therapy and surgical upper airway modifications could also result in a significant decrease in OSA severity in patients with POSA. 32,33 In summary, the combination of different treatment options for the alleviation of OSA is clearly underestimated, under-valued and underinvestigated in the field of sleep medicine. In order to reach the target, preferably an alleviation of the disease, it might indeed be necessary to prescribe two or more thera-pies with adjunctive therapies used as needed to supplement the primary treatment options. 13 In order to avoid incomplete alle-viation of OSA, our field needs to think out of the box and try to get rid of the taboo of combining different treatment options in the individual patients in order to reach a well-defined target correlating with long-term elimination of disease. Further research on the clinical effectiveness of the possible combina-tions to completely eliminate the patient's OSA is highly needed. CITATION Vanderveken OM. Combination therapy for obstructive sleep apnea in order to achieve complete disease alleviation: from taboo to new standard of care. Journal of Dental Sleep Medicine 2015;2(1):7–8.
Article
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Positional therapy (PT) is an effective therapy in positional obstructive sleep apnea syndrome (POSAS) when used, but the compliance of PT is low. The objective of this study was to investigate whether a new kind of PT is effective and can improve compliance. 29 patients were treated with the Sleep Position Trainer (SPT), 26 patients with the Tennis Ball Technique (TBT). At baseline and 1 month polysomnography, Epworth Sleepiness Scale (ESS) and the Quebec Sleep Questionnaire (QSQ) were taken. Daily compliance was objectively measured in both groups. Both therapies prevent supine sleep position to a median of 0% (min-max: SPT 0.0% to 67%, TBT 0.0% to 38.9%), resulting in a treatment success (AHI <5) in 68.0% of the SPT and 42.9% of the TBT patients. The ESS at baseline was <10 in both groups. Sleep quality parameters as wake after sleep onset (WASO; p = 0.001) and awakenings (p = 0.006) improved more in the SPT group. Total QSQ scores (0.4±0.2, p = 0.03) and the QSQ domains nocturnal symptoms (0.7±0.2, p = 0.01) and social interactions (0.8±0.3, p = 0.02) changed in favor of the SPT group. Effective compliance (≥4 h/night + ≥5 days/week) was 75.9% for the SPT and 42.3% for the TBT users (p = 0.01). In mild POSAS with normal EES the new SPT device and the standard TBT are equally effective in reducing respiratory indices. However, compared to the TBT, sleep quality, quality of life, and compliance improved significantly more in the SPT group. © 2014 American Academy of Sleep Medicine.
Article
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Abstract PURPOSE: The objective of this randomized controlled trial was to assess the additional effect of a chest-worn sleep position trainer (SPT) in patients with residual supine-dependent obstructive sleep apnea (sdOSA) under mandibular advancement device (MAD) therapy. METHODS: Baseline and follow-up polysomnography with MAD were performed. Twenty patients with sdOSA under MAD therapy underwent two consecutive randomized polysomnographies: one with SPT and one with combination of SPT + MAD. Data are presented as median (quartile 1, quartile 3). RESULTS: The SPT reduced the time spent in supine sleeping position compared to baseline and MAD therapy. Both MAD and SPT were individually effective in reducing the overall apnea/hypopnea index (AHI) significantly when compared to baseline from 20.8 (15.1; 33.6)/h at baseline to 11.0 (6.7; 13.8)/h and to 11.1 (3.5; 17.7)/h with MAD or SPT, respectively. The combination of SPT + MAD further reduced the overall AHI to 5.7 (3.6; 7.4), which was significantly lower than with MAD alone (p < 0.001) and SPT alone (p < 0.008), respectively. CONCLUSIONS: The results of this study indicate that combination of SPT + MAD leads to a higher therapeutic efficacy in patients with sdOSA under MAD therapy when compared to one of the treatment modalities alone.
Article
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Study objectives: To investigate effectiveness, long-term compliance, and effects on subjective sleep of the Sleep Position Trainer (SPT) in patients with position-dependent obstructive sleep apnea syndrome (POSAS). Design: Prospective, multicenter cohort study. Patients or participants: Adult patients with mild and moderate POSAS were included. Interventions: Patients were [corrected] asked to use the SPT for 6 mo. At baseline and after 1, 3, and 6 mo, questionnaires would be completed: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Questionnaire (FOSQ), and questions related to SPT use. Measurements and results: One hundred forty-five patients were included. SPT use and SPT data could not be retrieved in 39 patients. In the remaining 106 patients, median percentage of supine sleep decreased rapidly during SPT's training phase (day 3 to 9) to near-total avoidance of supine sleep. This decrease was maintained during the following months of treatment (21% at baseline versus 3% at 6 mo). SPT compliance, defined as more than 4 h of nightly use, was 64.4%. Regular use, defined as more than 4 h of usage over 5 nights/w, was 71.2%. Subjective compliance and regular use were 59.8% and 74.4%, respectively. Median ESS (11 to 8), PSQI (8 to 6), and FOSQ (87 to 103) values significantly improved compared with baseline. Conclusions: Positional therapy using the Sleep Position Trainer (SPT) effectively diminished the percentage of supine sleep and subjective sleepiness and improved sleep related quality of life in patients with mild to moderate position-dependent obstructive sleep apnea syndrome. SPT treatment appeared to have sustained effects over 6 months. SPT compliance and regular use rate were relatively good. Subjective and objective compliance data corresponded well. The lack of a placebo-controlled group limited the efficacy of conclusions. Citation: van Maamen JP, de Vries N. Long-term effectiveness and compliance of positional therapy with the Sleep Position Trainer in the treatment of positional obstructive sleep apnea syndrome.
Article
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Oral appliances (OA) have emerged as an alternative to continuous positive airway pressure (CPAP) for Obstructive Sleep Apnoea (OSA) treatment. The most commonly used OA reduces upper airway collapse by advancing the mandible (OAm). There is a strong evidence base demonstrating OAm improve OSA in the majority of patients, including some with more severe disease. However OAm are not efficacious for all, with approximately one third of patients experiencing no therapeutic benefit. OAm are generally well tolerated, although short-term adverse effects during acclimatization are common. Long-term dental changes do occur, but these are for the most part subclinical and do not preclude continued use. Patients often prefer OAm to gold-standard Continuous Positive Airway Pressure (CPAP) treatment. Head-to-head trials confirm CPAP is superior in reducing OSA parameters on polysomnography, however this greater efficacy does not necessarily translate into better health outcomes in clinical practice. Comparable effectiveness of OAm and CPAP has been attributed to higher reported nightly use of OAm, suggesting that inferiority in reducing apneic events may be counteracted by greater treatment adherence. Recently, significant advances in commercially available OAm technologies have been made. Remotely controlled mandibular positioners have the potential to identify treatment responders and the level of therapeutic advancement required in single night titration polysomnography. Objective monitoring of OAm adherence using small embedded temperature sensing data loggers is now available and will enhance clinical practice and research. These technologies will further enhance efficacy and effectiveness of OAm treatment for OSA.
Article
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Background: Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea. Methods: Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial. Results: The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%. Conclusions: In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).
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Background: Assessment of the overall therapeutic effectiveness of oral appliance therapy can only be realized through objectively measured compliance. The aims of this study were to assess objectively measured compliance during oral appliance therapy at 1-year follow-up and to compare these data with self-reported use. Methods: Fifty-one eligible patients were enrolled in this 1-year prospective clinical study (men, 61%; mean age, 49 ± 10 years; apnea-hypopnea index, 18.0 ± 11.9 events/h sleep; BMI, 26.6 ± 4.1 kg/m²). Objective compliance during oral appliance therapy at 1-year follow-up was assessed with a microsensor thermometer. Subjective compliance was assessed by self-report. Patients with a mean objectively measured use of ≥ 4 h/night on 70% of nights monitored were considered regular users. The mean disease alleviation was calculated as a measure of overall therapeutic effectiveness. Results: High agreement between objective and subjective compliance data at 1-year follow-up was reported (intraclass correlation coefficient, 0.8; 95% CI, 0.5-0.9), showing a mean subjective overestimation of 30 min (95% CI, -3.1 to 1.9; P = .02). The discontinuation rate at 1-year follow-up was 9.8%. The objective mean use rate was 6.4 ± 1.7 h/night at 1-year follow-up in continuing users, with a regular use rate of 83%. The mean disease alleviation was 54.9%. Conclusions: This study is the first to our knowledge to report the 1-year results of objectively measured compliance during oral appliance therapy. In addition, a high agreement between objective and subjective compliance data were reported, with a mean subjective overestimation of 30 min. Trial registry: ClinicalTrials.gov; No.: NCT01284881; URL: www.clinicaltrials.gov.
Article
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Background: Oral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report. Methods: In this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0 ± 11.9/h; age 47 ± 10 y; BMI 26.6 ± 4.0 kg/m(2); men/women: 31/20). Patients were unaware of the purpose of the study. Results: No microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6 ± 1.3 h per day with a regular OA users' rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%. Conclusions: The results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.
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In a retrospective cohort study, we evaluated whether improvements in nasal continuous positive airway pressure (nCPAP) technology, particularly the introduction of automatic adjustment of the nCPAP pressure (auto-CPAP), have led to better acceptance and (long-term) compliance in patients with obstructive sleep apnea syndrome (OSAS) as compared to earlier reported data. Questionnaires were sent to 256 patients, who were referred to our clinic for an overnight polysomnography from January 1997 to July 2005 and received nCPAP therapy for OSAS. Of the 256 patients, 24 patients were unavailable for follow-up. Of the remaining 232 patients, 58 patients (25%) had discontinued therapy, while 174 patients (75%) were still using nCPAP after 2 months to 8 years of follow-up. One Hundred and thirty eight (79%) of these 174 patients used nCPAP for at least 4 h/night during >or= 5 nights/week, 82,1% of the conventional nCPAP (fixed pressure CPAP) group (n = 78) and 77,1% of the auto-CPAP group (n = 96). Therefore, including the 58 failures, only 59.5% of patients can be seen as compliant. There were no statistical differences between the fixed pressure CPAP and auto-CPAP users, and between the compliant and non-compliant users according to age, BMI, AHI and Epworth sleepiness scale (ESS). Auto-CPAP patients used significantly more cm H2O. The long-term compliance of nCPAP therapy has have increased only slightly since the introduction of the fixed pressure CPAP 25 years ago, in spite of many efforts to improve it. It seems that a plateau has been reached and that it is unrealistic to aim at a substantially higher compliance rate.
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Despite the high efficacy of continuous positive airway pressure (CPAP) to reverse upper airway obstruction in sleep apnea, treatment effectiveness is limited by variable adherence to prescribed therapy. When adherence is defined as greater than 4 hours of nightly use, 46 to 83% of patients with obstructive sleep apnea have been reported to be nonadherent to treatment. Evidence suggests that use of CPAP for longer than 6 hours decreases sleepiness, improves daily functioning, and restores memory to normal levels. The decision to embrace CPAP occurs during the first few days of treatment. Although many strategies in patient interface with CPAP or machine modality are marketed to improve CPAP usage, there are few data to support this. No single factor has been consistently identified as predictive of adherence. Patient perception of symptoms and improvement in sleepiness and daily functioning may be more important in determining patterns of use than physiologic aspects of disease severity. Emerging data suggest that various behavioral interventions may be effective in improving CPAP adherence.
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With this systematic review we aimed to determine the prevalence of OSA in adults in the general population and how it varied between population sub-groups. Twenty-four studies out of 3,807 found by systematically searching PubMed and EMBASE databases were included in this review. Substantial methodological heterogeneity in population prevalence studies has caused a wide variation in the reported prevalence, which, in general, is high. At ≥5 Apnea-Hypopnea Index (AHI), the overall population prevalence ranged from 9% to 38% and was higher in men. It increased with increasing age and, in some elderly groups, was as high as 90% in men and 78% in women. At ≥15 AHI, the prevalence in the general adult population ranged from 6% to 17%, being as high as 49% in the advanced ages. OSA prevalence was also greater in obese men and women. This systematic review of the overall body of evidence confirms that advancing age, male sex, and higher body-mass index increase OSA prevalence. The need to (a) consider OSA as having a continuum in the general population and (b) generate consensus on methodology and diagnostic threshold to define OSA so that the prevalence of OSA can be validly compared across regions and countries, and within age-/sex-specific subgroups, are highlighted.
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Study objective To evaluate the tolerability and to find predictors of treatment success for an individually adjusted, one-piece mandibular advancement device in patients with snoring and obstructive sleep apnea. Design Prospective study. Setting Departments of Respiratory Medicine and Orthodontics, Umeå University. Patients Six hundred nineteen of 630 patients (98%), who consecutively received treatment for sleep apnea and snoring from February 1989 to August 2000, were followed up. They had a mean apnea-hypopnea index of 16 (range, 0.0 to 76) and a mean body mass index of 28 (range, 19 to 42). Measurements Interviews, questionnaires, and overnight sleep apnea recordings. Patients with an apnea-hypopnea index of ≥ 10 in the supine and/or lateral position were considered to have obstructive sleep apnea. A lateral apnea-hypopnea index of < 10, together with a supine apnea-hypopnea index of ≥ 10, defined supine-dependent sleep apneas. Results One hundred forty-eight of the 619 patients (24%) discontinued treatment. Female gender predicted treatment success, defined as an apnea-hypopnea index of < 10 in both the supine and lateral positions, with an odds ratio of 2.4 (p = 0.01). In the women, the odds ratios for treatment success were 12 for mild sleep apnea (p = 0.04), and 0.1 for complaints of nasal obstruction (p = 0.03). In the men, the odds ratios for treatment success were 6.0 for supine-dependent sleep apneas (p < 0.001), 2.5 for mild sleep apnea (p = 0.04), 1.3 for each millimeter of mandibular advancement (p = 0.03), and 0.8 for each kilogram of weight increase (p = 0.001). Conclusions The mandibular advancement device is recommended for women with sleep apnea, for men with supine-dependent sleep apneas defined by a lateral apnea-hypopnea index of < 10, and for snorers without sleep apnea. Men who increase in weight during treatment reduce their chance of treatment success and are advised to be followed up with a new sleep apnea recording with the device.