Trial ID or NCT#

NCT00772044

Status

NOT RECRUITING

Purpose

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

Investigator(s)

Clete A. Kushida, MD, PhD, FAASM
Sleep specialist, Neurologist
Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center

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CONTACT

Chia-Yu Cardell
(650) 721-7576