Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Public ClinicalTrials.gov record NCT00772044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00772044
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2008 (Type not available)
- Primary completion
- Sep 2009 (Actual)
- Completion
- Dec 2009 (Actual)
- Last update posted
- Apr 1, 2010
2008 – 2009
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | — |
| Pulmonary Associates | Phoenix | Arizona | 85006 | — |
| Stanford Center for Human Sleep Research | Redwood City | California | 94063 | — |
| Gaylord Sleep Medicine | Wallingford | Connecticut | 06492 | — |
| University Of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Sleep Disorders Center of Georgia | Atlanta | Georgia | 30342 | — |
| Chicago Sleep Group of Suburban Lung Associates | Elk Grove Village | Illinois | 60007 | — |
| Kentucky Research Group | Louisville | Kentucky | 40217 | — |
| Sleep Health Center | Brighton | Massachusetts | 02135 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | — |
| The Corvallis Clinic | Corvallis | Oregon | 97330 | — |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | — |
| Sleep Medicine Associates of Texas | Dallas | Texas | 75231 | — |
| Sleep Therapy and Research Center | San Antonio | Texas | 07829 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00772044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 1, 2010 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00772044 live on ClinicalTrials.gov.