• Richard B Berry, Meir H Kryger, and Clifford A Massie.
• Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL 32610, USA. sleep_doc@msn.com
• Sleep. 2011 Apr 1;34(4):479-85.

Study ObjectivesInvestigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).DesignA prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.Setting19 sites including both academic and private sleep disorder centersPatientsObstructive sleep apnea with a pre-study AHI ≥10/hourInterventionsTreatment 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 ResultsAt 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%.ConclusionsThe 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 InformationRegistrationsClinicalTrials.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 NumberNCT00772044.

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