HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

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

AbstractSTUDY 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.
AuthorsRichard B Berry, Meir H Kryger, Clifford A Massie
JournalSleep (Sleep) Vol. 34 Issue 4 Pg. 479-85 (Apr 01 2011) ISSN: 1550-9109 [Electronic] United States
PMID21461326 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Topics
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Polysomnography
  • Positive-Pressure Respiration (instrumentation)
  • Prospective Studies
  • Sleep
  • Sleep Apnea, Obstructive (therapy)
  • Treatment Outcome

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: