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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:
Patient acceptance, in terms of:
Please see summary above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provent | Active Comparator | Those receiving the active device |
|
| Sham | Sham Comparator | Those receiving sham device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provent Professional Sleep Apnea Therapy Device | Device | Application of active device (Provent) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Berry, M.D. | University of Florida | Principal Investigator |
| Connie A Rey | Ventus Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | United States | ||
| Pulmonary Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21461326 | Derived | Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011 Apr 1;34(4):479-85. doi: 10.1093/sleep/34.4.479. |
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| Sham Device | Device | Sham device will be applied |
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Stanford Center for Human Sleep Research | Redwood City | California | 94063 | United States |
| Gaylord Sleep Medicine | Wallingford | Connecticut | 06492 | United States |
| University Of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Sleep Disorders Center of Georgia | Atlanta | Georgia | 30342 | United States |
| Chicago Sleep Group of Suburban Lung Associates | Elk Grove Village | Illinois | 60007 | United States |
| Kentucky Research Group | Louisville | Kentucky | 40217 | United States |
| Sleep Health Center | Brighton | Massachusetts | 02135 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | United States |
| The Corvallis Clinic | Corvallis | Oregon | 97330 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Sleep Medicine Associates of Texas | Dallas | Texas | 75231 | United States |
| Sleep Therapy and Research Center | San Antonio | Texas | 07829 | United States |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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