[Show abstract][Hide abstract] ABSTRACT: Objective:
To describe the 36-month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS).
A multicenter prospective cohort study.
Industry-supported multicenter academic and clinical setting.
Participants (n = 116) at 36 months from a cohort of 126 implanted participants.
Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea-hypopnea index, oxygen desaturation index, other PSG measures, self-reported measures of sleepiness, sleep-related quality of life, and snoring.
Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea-hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months.
Long-term 3-year improvements in objective respiratory and subjective quality-of-life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA.
Full-text · Article · Nov 2015 · Otolaryngology Head and Neck Surgery
[Show abstract][Hide abstract] ABSTRACT: Address reprint requests and correspondence: Nico de Vries, MD, Department of Otolaryngology, Head and Neck Surgery, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium.
No preview · Article · Oct 2015 · Operative Techniques in Otolaryngology-Head and Neck Surgery
[Show abstract][Hide abstract] ABSTRACT: Selective upper airway stimulation of the hypoglossal nerve is a novel therapy option for obstructive sleep apnea. Different tongue motions were observed after surgery during active therapy.
We examined tongue motions in 14 patients (mean age 51 ± 10 years) who received an implantation of an upper airway stimulation system (Inspire Medical Systems) from September 2013 to February 2014 in three different implantation centers in Germany after surgery. Sleep recording was performed preoperatively: 2 months (M02) and 6 months (M06) after surgery.
There were three different tongue motions observed after surgery at 1 month (M01), M02, and M06 after surgery: bilateral protrusion (BP), right protrusion (RP), and mixed activation (MA). At M01: 10 BP, 2 RP, and 2 MA; at M02: 12 BP, 0 RP, and 2 MA; and at M06: 12 BP, 0 RP, and 2 MA could be detected. The average apnea-hypopnea index (AHI) was reduced from 32.5 ± 14.2/h before surgery to 17.9 ± 23.3/h at M02 and 14.1 ± 19.8/h at M06. An increased reduction in AHI was found in BP and RP group (Baseline: 29.6 ± 12.6/h; M02: 12.06 ± 14.1/h; M06: 9.7 ± 12.6/h) compared to the MA group (Baseline 49.6 ± 13.8/h; M02: 49.7 ± 5.1/h; M06: 40.5 ± 4.1/h).
These findings suggest that the postoperative tongue motions in upper airway stimulation are associated with the therapy outcome. The stimulation electrode placement on the hypoglossal nerve for selective muscle recruitment may play a role in the mechanism of action.
No preview · Article · Aug 2015 · Sleep And Breathing
[Show abstract][Hide abstract] ABSTRACT: Objective. To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures. Study Design. A randomized controlled therapy withdrawal study. Setting. Industry-supported multicenter academic and clinical setting. Subjects. A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants. Methods. Participants were randomized to either therapy maintenance ("ON'') group or therapy withdrawal ("OFF'') group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed. Results. Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months. Conclusion. Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.
No preview · Article · Sep 2014 · Otolaryngology Head and Neck Surgery
[Show abstract][Hide abstract] ABSTRACT: Upper-airway stimulation (UAS) using a unilateral implantable neurostimulator for the
hypoglossal nerve is an effective therapy for obstructive sleep apnoea patients with continuous positive
airway pressure intolerance. This study evaluated stimulation effects on retropalatal and retrolingual
dimensions during drug-induced sedation compared with wakefulness to assess mechanistic relationships in
response to UAS.
Patients with an implanted stimulator underwent nasal video endoscopy while awake and/or during
drug-induced sedation in the supine position. The cross-sectional area, anterior–posterior and lateral
dimensions of the retropalatal and retrolingual regions were measured during baseline and stimulation.
15 patients underwent endoscopy while awake and 12 underwent drug-induced sedation endoscopy.
Increased levels of stimulation were associated with increased area of both the retropalatal and retrolingual
regions. During wakefulness, a therapeutic level of stimulation increased the retropalatal area by 56.4%
(p50.002) and retrolingual area by 184.1% (p50.006). During stimulation, the retropalatal area enlarged in
the anterior–posterior dimension while retrolingual area enlarged in both anterior–posterior and lateral
dimensions. During drug-induced sedation endoscopy, the same stimulation increased the retropalatal
area by 180.0% (p50.002) and retrolingual area by 130.1% (p50.008). Therapy responders had larger
retropalatal enlargement with stimulation than nonresponders.
UAS increases both the retropalatal and retrolingual areas. This multilevel enlargement may explain
reductions of the apnoea–hypopnoea index in selected patients receiving this therapy.
Full-text · Article · Sep 2014 · European Respiratory Journal
[Show abstract][Hide abstract] ABSTRACT: Introduction
Primary snoring is per se not a sickness, but can often lead to social impairment. Snoring treatment strategies should, therefore, be associated with the lowest possible risk and be well tolerated. Snoring seems to be amplified in the supine position and sometimes appears only then. Study data concerning this matter are inhomogeneous. Preliminary evidence suggests that affected individuals snore less or do not snore anymore if the position of the head is lateral despite a supine body position. Thus, it remains unclear whether changing the head position is able to diminish snoring.
Materials and methods
Therefore, an anti-snoring pillow consisting of incorporated small air cushions, a sensor plate, and two microphones was developed (Sissel® Silencium). If the microphones detect snoring sounds, the air cushions start filling with air and cause a gentle turning of the head. Subjects were selected by the symptom “snoring”. No sleep recording had been previously taken. All patients received the pillow for at least four nights. For the analysis, two nights with activated and two with no pillow activation were retrospectively compared.
In a total of 157 subjects (142 men and 15 women; average age 54 ± 9.6 years), a significant snoring reduction was observed. The snoring duration per total recording time with the inactivated pillow could be reduced from 48 ± 17 to 16 ± 9 % by activating the pillow, which represents an improvement of 67 ± 14 %.
Thus far, the tested pillow significantly reduces snoring duration. However, it still remains unclear whether arousals caused by changing the head position, a whole body rotation induced by head twist, or even the exclusive head rotation cause this snoring-reducing effect. Based on these preliminary data, prospective randomized trials are necessary in order to objectively and subjectively validate the effectiveness of the tested device.
No preview · Article · Jun 2014 · Somnologie - Schlafforschung und Schlafmedizin
[Show abstract][Hide abstract] ABSTRACT: Background:
Although drug-induced sedation endoscopy (DISE) represents the most widespread diagnostic tool for upper airway endoscopic evaluation of snoring and obstructive sleep apnea hypopnea syndrome (OSAHS), many controversies exist about how to perform the sedation, the indications for DISE, and how to report DISE findings. The present position paper reports on a consensus as proposed by a group of European experts in the field of DISE after discussion during a recent dedicated meeting.
The authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centers in order to provide a standardization of the DISE procedure and an in-depth insight in the main aspects of this technique.
A proposal of the DISE procedure standardization has been achieved with a general agreement concerning the terminology, indications, contraindications, required preliminary examinations, setting, technical equipment required, staffing, local anesthesia and nasal decongestion, patient positioning, basis and special diagnostic maneuvers, and the applied sedation drugs and observation windows. Otherwise, no consensus has been reached on a scoring and classification system.
Although consensus has been reached on several aspects of the DISE procedure, some topics remain open to future research, such as a better analysis of the importance of positional aspects during DISE and a further comparison of the differences in degree, level and pattern of upper airway collapse observed during DISE versus during natural sleep and awake endoscopy. Finally, a universally accepted scoring and classification system is lacking.
Full-text · Article · May 2014 · Sleep And Breathing
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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%.
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.).
Full-text · Article · Jan 2014 · New England Journal of Medicine
[Show abstract][Hide abstract] ABSTRACT: The treatment of diseases of the lingual tonsils is still under debate, and surgical interventions are often associated with significant morbidity and complications. The aim of the present study was to evaluate the safety of lingual tonsillectomy using cold ablation (coblation) as a new treatment of lingual tonsil diseases. In this retrospective, bicentric study, we included all patients between 2005 and 2012 who underwent cold ablation (Coblation(®)) of the lingual tonsils. We assessed the frequency of postoperative complications based on the patients' charts. A total of 108 patients (47 ± 13, 6 years) underwent lingual tonsillectomy using coblation. All patients were operated on under general anesthesia as inpatients. Intraoperative complications did not occur. Three patients (2.8 %) needed revision surgery due to postoperative hemorrhage, and in one of those cases, three revisions were necessary. There was no postoperative airway compromise and no need for tracheostomy. There was no hypoglossal nerve paralysis, but in the case needing multiple revisions, a weakness of the hypoglossal nerve persisted. In all the cases, oral intake was possible with adequate analgesia. Coblation of the tongue base is a safe procedure with a relatively low rate of postoperative complications. Postoperative hemorrhage is the most relevant complication that occurred in our series of patients. Future studies are needed to evaluate the efficacy of the procedure in the treatment of obstructive sleep apnea.
No preview · Article · Jan 2014 · Archives of Oto-Rhino-Laryngology
[Show abstract][Hide abstract] ABSTRACT: These guidelines aim to facilitate high quality medical care of adults with snoring problems. The guidelines were devised for application in both in- and outpatient environments and are directed primarily at all those concerned with the diagnosis and therapy of snoring. According to the AWMF three-level concept, these represent S2k guidelines.A satisfactory definition of snoring does not currently exist. Snoring is the result of vibration of soft tissue structures in narrow regions of the upper airway during breathing while asleep. Ultimately, these vibrations are caused by the sleep-associated decrease in muscle tone in the area of the upper airway dilator muscles. A multitude of risk factors for snoring have been described and its occurrence is multifactorial. Data relating to the frequency of snoring vary widely, depending on the way in which the data are collected. Snoring is usually observed in middle-aged individuals and affected males predominate. Clinical diagnosis of snoring should comprise a free evaluation of the patient's medical history. Where possible this should also involve their bed partner and the case history can be complimented by questionnaires. To determine the airflow relevant structures, a clinical examination of the nose should be performed. This examination may also include nasal endoscopy. Examination of the oropharynx is particularly important and should be performed. The larynx and the hypopharynx should be examined. The size of the tongue and the condition of the mucous membranes should be recorded as part of the oral cavity examination, as should the results of a dental assessment. Facial skeleton morphology should be assessed for orientation purposes. Technical examinations may be advisable in individual cases. In the instance of suspected sleep-related breathing disorders, relevant comorbidities or where treatment for snoring has been requested, an objective sleep medicine examination should be performed. Snoring is not-at least as we currently understand it-a disease associated with a medical threat; therefore there is currently no medical necessity to treat the condition. All overweight patients with snoring problems should strive to lose weight. If snoring is associated with the supine position, positional therapy can be considered. Some cases of snoring can be appropriately treated using an intraoral device. Selected minimally invasive surgical procedures on the soft palate can be recommended to treat snoring, provided that examinations have revealed a suitable anatomy. The choice of technique is determined primarily by the individual anatomy. At an appropriate interval after the commencement or completion a therapeutic measure, a follow-up examination should be conducted to assess the success of the therapy and to aid in the planning of any further treatments.
[Show abstract][Hide abstract] ABSTRACT: Objectives: Determine safety and effectiveness of upper airway stimulation for treatment of obstructive sleep apnea (OSA) in a prospective, multi-center trial; with subsequent randomized, controlled therapy withdrawal evaluation.
No preview · Article · Aug 2013 · Otolaryngology Head and Neck Surgery