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A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial.

ABSTRACT: STUDY OBJECTIVES:Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). DESIGN:A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial. SETTING:19 sites including both academic and private sleep disorder centers PATIENTS:Obstructive sleep apnea with a pre-study AHI ?10/hour INTERVENTIONS:Treatment with a nasal EPAP device (N=127) or similar appearing sham device (N=123) for 3 months. Polysomnography (PSG) was performed on 2 non-consecutive nights (random order: device-on, device-off) at week 1 and after 3 months of treatment. Analysis of an intention to treat group (ITT) (patients completing week 1 PSGs) (EPAP N=119, sham N=110) was performed. MEASUREMENTS AND RESULTS:At week 1, the median AHI value (device-on versus device-off) was significantly lower with EPAP (5.0 versus 13.8 events/h, P<0.0001) but not sham (11.6 versus 11.1 events/h, P=NS); the decrease in the AHI (median) was greater (-52.7% vs. -7.3%, P<0.0001) for the ITT group. At month 3, the percentage decrease in the AHI was 42.7% (EPAP) and 10.1% (sham), P<0.0001. Over 3 months of EPAP treatment the Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P<0.0001), and the median percentage of reported nights used (entire night) was 88.2%. CONCLUSIONS:The nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence. CLINICAL TRIAL INFORMATION: REGISTRATIONS:ClinicalTrials.gov. Trial name: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO). URL: http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1. REGISTRATION NUMBER:NCT00772044.

SUBMITTER: Berry RB

PROVIDER: S-EPMC3065258 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial.

Berry Richard B RB Kryger Meir H MH Massie Clifford A CA

Sleep 20110401 4

<h4>Study objectives</h4>Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).<h4>Design</h4>A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.<h4>Setting</h4>19 sites including both academic and private sleep disorder centers<h4>Patients</h4>Obstructive sleep apnea with a pre-study AHI ≥10/hour<h4>Interventions</h4>Treatment with a nasal EPAP device (N=127) ...[more]

PMID: 21461326

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Project description:Study objectivesEvaluate 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).DesignA prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trialSetting13 sites including both academic and private sleep disorder centersPatientsOSA 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.InterventionsTreatment 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 resultsOf 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%.ConclusionsNasal 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.Clinical trial registrationClinicalTrials.gov TRIAL NAME: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E). URL: http://clinicaltrials.gov/ct2/show/NCT00849043?term=Ventus+Medical&rank=2.Registration numberNCT00849043.

Dataset Information

A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial.

Publications

A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial.

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