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

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. 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.