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

Primary Contact:

Chia-Yu Cardell 6507217576

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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