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NCT00772044 · ClinicalTrials.gov registry record · Phase 4
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
A Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea, sponsored by Ventus Medical.
- Completed
- Registry status
- Phase 4
- Development phase
- 250
- Enrollment target
- 17
- Study locations
NCT00772044: Completed Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea, sponsored by Ventus Medical.
NCT00772044 is a Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea that has completed, run by Ventus Medical. The registered enrollment target is 250 participants, above the 147-participant average among 14 other OSA trials with a reported enrollment target (70% higher). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00772044, a Phase 4 study of OSA and Obstructive Sleep Apnea Hypopnea, has completed, sponsored by Ventus Medical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 250 participants
- Enrollment target
- 17
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DEVICE Sham Device
- DEVICE Provent Professional Sleep Apnea Therapy Device
Study Locations (17)
Arizona
- Pulmonary Associates - Glendale
- Pulmonary Associates - Phoenix
Michigan
- Wayne State University - Detroit
- Borgess Research Institute - Kalamazoo
Texas
- Sleep Medicine Associates of Texas - Dallas
- Sleep Therapy and Research Center - San Antonio
California
- Stanford Center for Human Sleep Research - Redwood City
Connecticut
- Gaylord Sleep Medicine - Wallingford
Florida
- University Of Florida College of Medicine - Gainesville
Georgia
- Sleep Disorders Center of Georgia - Atlanta
Illinois
- Chicago Sleep Group of Suburban Lung Associates - Elk Grove Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00772044 record still lists
NCT00772044 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 147-participant average among 14 other OSA trials with a reported enrollment target (70% higher).
The record links to 3 conditions, with OSA appearing as the primary indexed condition, and to 2 interventions - of which Sham Device is the first listed.
NCT00772044 lists 17 locations in 14 states (Arizona, Michigan, Texas).
Frequently Asked Questions
What is clinical trial NCT00772044 about?
NCT00772044 is a clinical study titled "Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea". 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 f...
What is the current status of trial NCT00772044?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2008-11. Estimated completion is 2009-12.
What conditions does trial NCT00772044 study?
This clinical trial studies the following conditions: OSA, Obstructive Sleep Apnea Hypopnea, OSAH.
What interventions are being tested in trial NCT00772044?
The interventions under investigation include: Sham Device (DEVICE), Provent Professional Sleep Apnea Therapy Device (DEVICE).
Who is sponsoring clinical trial NCT00772044?
This trial is sponsored by Ventus Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00772044 being conducted?
This trial has 17 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00772044's enrollment target sits among peer trials
250 4th of 14 higher than 11 of 14 other OSA trials
participants (enrollment target), bucketed by value
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