Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No


Clete A. Kushida, MD, PhD
Clete A. Kushida, MD, PhD
Sleep specialist, Neurologist
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)

Contact us to find out if this trial is right for you.


Chia-Yu Cardell
(650) 721-7576