NCT00772044

Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Ventus Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: * AHI with device on vs. off at 3 months, controlling for sleep position * Oxygen desaturation index with device on vs. off * Arousal index with device on vs. off * Duration of snoring with device on vs. off * Epworth Sleepiness Scale Patient acceptance, in terms of: * Refusal rate at screening * Discontinuation rate during follow-up * Daily compliance rate * Device-related adverse events * Serious adverse events

Detailed description

Please see summary above

Conditions

• Obstructive Sleep Apnea Hypopnea
• OSA
• OSAH

Interventions

Type	Name	Description
DEVICE	Provent Professional Sleep Apnea Therapy Device	Application of active device (Provent)
DEVICE	Sham Device	Sham device will be applied

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2008-10-15
• Last updated: 2010-04-01

Locations

17 sites across 1 country: United States