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
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
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : Sham Device
- device : Provent Professional Sleep Apnea Therapy Device
Phase: Phase 4
Ages Eligible For Study:
1. Age > 18 years 2. Diagnosis of OSA 3. AHI > 10 on diagnostic PSG performed within last 3 months 4. Investigator believes that subject can benefit from OSA tx 5. Subject understands and is willing and able to comply with study requirements