title: A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial.
abstract: OBJECTIVE
  Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).
  
  
  METHODS
  A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.
  
  
  METHODS
  19 sites including both academic and private sleep disorder centers
  
  
  METHODS
  Obstructive sleep apnea with a pre-study AHI ≥10/hour
  
  
  METHODS
  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.
  
  
  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.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT00772044.
authors: Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL 32610, USA. sleep_doc@msn.com
authors: Richard B
authors: RB
authors: Berry
authors: Meir H
authors: MH
authors: Kryger
authors: Clifford A
authors: CA
authors: Massie
mesh_terms: D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D011175:Positive-Pressure Respiration / Q000295:instrumentation*; D011446:Prospective Studies; D012890:Sleep; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D016896:Treatment Outcome