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

Trial ID or NCT#

NCT00772044

Status

not recruiting iconNOT 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

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

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

Contact

Chia-Yu Cardell
6507217576