Clinical Trials Directory

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.

Investigator(s):

Intervention(s):

  • device : Sham Device
  • device : Provent Professional Sleep Apnea Therapy Device

Phase: Phase 4

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

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

External Links

Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chia-Yu Cardell
6507217576
Not Recruiting

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