A convenient expiratory positive airway pressure nasal device for the treatment of sleep apnea in patients non-adherent with continuous positive airway pressure

Sleep Medicine and Research Center, St. Luke's Hospital, 232 S. Woods Mill Rd., Chesterfield, MO, USA.
Sleep Medicine (Impact Factor: 3.15). 02/2011; 12(2):147-52. DOI: 10.1016/j.sleep.2010.06.011
Source: PubMed


While continuous positive airway pressure (CPAP) effectively treats obstructive sleep apnea (OSA), adherence to CPAP is suboptimal. The short-term efficacy of and adherence with a convenient expiratory positive airway pressure (EPAP) nasal device was evaluated in OSA patients non-adherent with CPAP.
Participants were OSA patients who refused CPAP or used CPAP less than 3 h per night. After demonstrating tolerability to the EPAP device during approximately 1 week of home use, patients underwent a screening/baseline polysomnogram (PSG1) and a treatment PSG (PSG2). Patients meeting prespecified efficacy criteria underwent PSG3 after about 5 weeks of EPAP treatment.
Forty-seven of 59 eligible patients (80%) tolerated the device and underwent PSG1. Forty-three patients (27 m, 16f; 53.7±10.9 years) met AHI entry criteria and underwent PSG2. Mean AHI decreased from 43.3±29.0 at baseline to 27.0±26.7 (p<0.001) at PSG2. Twenty-four patients (56%) met efficacy criteria; their mean AHI was 31.9±19.8, 11.0±7.9, 16.4±12.2 at PSG1, PSG2, and PSG3, respectively (p<0.001, PSG1 vs. both PSG2 and PSG3). Mean Epworth Sleepiness Scale (ESS) scores were 12.3±4.8 at baseline, 11.1±5.1 at PSG1, and 8.7±4.4 at PSG3 (p=0.001 compared to baseline). Device use was reported an average of 92% of all sleep hours.
The improvements in AHI and ESS, combined with the high degree of treatment adherence observed, suggest that the convenient EPAP device tested may become a useful therapeutic option for OSA.

Download full-text


Available from: Paula K Schweitzer,
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Nasal expiratory positive airway pressure (nEPAP) delivered with a disposable device (Provent, Ventus Medical) has been shown to improve sleep-disordered breathing (SDB) in some subjects. Possible mechanisms of action are 1) increased functional residual capacity (FRC), producing tracheal traction and reducing upper airway (UA) collapsibility, and 2) passive dilatation of the airway by the expiratory pressure, carrying over into inspiration. Using MRI, we estimated change in FRC and ventilation, as well as UA cross-sectional area (CSA), in awake patients breathing on and off the nEPAP device. Ten patients with SDB underwent nocturnal polysomnography and MRI with and without nEPAP. Simultaneous images of the lung and UA were obtained at 6 images/s. Image sequences were obtained during mouth and nose breathing with and without the nEPAP device. The nEPAP device produced an end-expiratory pressure of 4-17 cmH(2)O. End-tidal Pco(2) rose from 39.7 ± 5.3 to 47.1 ± 6.0 Torr (P < 0.01). Lung volume changes were estimated from sagittal MRI of the right lung. Changes in UA CSA were calculated from transverse MRI at the level of the pharynx above the epiglottis. FRC determined by MRI was well correlated to FRC determined by N(2) washout (r = 0.76, P = 0.03). nEPAP resulted in a consistent increase in FRC (46 ± 29%, P < 0.001) and decrease in ventilation (50 ± 15%, P < 0.001), with no change in respiratory frequency. UA CSA at end expiration showed a trend to increase. During wakefulness, nEPAP caused significant hyperinflation, consistent with an increase in tracheal traction and a decrease in UA collapsibility. Direct imaging effects on the UA were less consistent, but there was a trend to dilatation. Finally, we showed significant hypoventilation and rise in Pco(2) during use of the nEPAP device during wakefulness and sleep. Thus, at least three mechanisms of action have the potential to contribute to the therapeutic effect of nEPAP on SDB.
    Journal of Applied Physiology 07/2011; 111(5):1400-9. DOI:10.1152/japplphysiol.00218.2011 · 3.06 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Study objectives: Evaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA). Design: A prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trial Setting: 13 sites including both academic and private sleep disorder centers Patients: OSA patients in the EPAP arm of the EPAP vs sham randomized study who used the EPAP device >= 4 h per night, >= 5 nights per week on average during months 1 and 2 of the 3-month trial and had >= 50% reduction in AHI or AHI reduction to < 10 documented by polysomnography, comparing the 3-month device-on PSG to the week-one device-off PSG. Interventions: Treatment with a nasal EPAP device (N = 41) for 12 months. Polysomnography (PSG) on the patients wearing the device was performed after 12 months of treatment. The month 12 device-on PSG data from the analyzable subject cohort (N = 34) was compared to the week 1 device-off PSG from the EPAP vs sham trial. Measurements and results: Of the 51 patients eligible, 34 were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events/h (week 1 device-off versus month 12 device-on). The decrease in the AHI (median) was 71.3% (p < 0.001). The median proportion of sleep time with snoring was reduced by 74.4% (p < 0.001). Over 12 months of EPAP treatment, the Epworth Sleepiness Scale decreased (11.1 +/- 4.2 to 6.0 +/- 3.2, p < 0.001), and the median percentage of reported nights used (entire night) was 89.3%. Conclusions: Nasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment. Long-term adherence to EPAP was excellent in those who had a positive clinical response at month 3 of the EPAP vs sham study.
    Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 10/2011; 7(5):449-53B. DOI:10.5664/JCSM.1304 · 3.05 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Obstructive sleep apnea (OSA) is a prevalent disorder often associated with daytime sleepiness, cognitive dysfunction, and adverse cardiovascular consequences. Available therapies are limited by either lack of long-term adherence or low response rates. Two emerging therapies hold promise in providing alternatives to patients with OSA. The first stems from the importance of the upper-airway dilator muscles in maintaining pharyngeal stability. Electrical stimulation of the genioglossus muscle improves both upper-airway diameter and ameliorates pharyngeal obstruction. The results of phase I and II clinical trials hold promise, but the reported improvements in the apnea-hypopnea index vary between subjects and concerns about long-term safety await long-term studies. The second technology relies on creating an increased expiratory nasal resistance via a bidirectional valve designed to be worn just inside the nostrils. Initial findings of clinical trials suggest reduction in severity of sleep apnea and subjective daytime sleepiness. Considerable heterogeneity in response to the nasal device was noted despite the high adherence rates. It remains unclear which patients will likely benefit a priori from these devices.
    Beiträge zur Klinik der Tuberkulose 02/2012; 190(4):365-71. DOI:10.1007/s00408-012-9380-1 · 2.27 Impact Factor
Show more