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The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provent | Provent Professional Sleep Apnea Therapy device |
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| Measure | Description | Time Frame |
|---|---|---|
| To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the subjects quality of life | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
1. The patient must continue to not meet all of the exclusion criteria of protocol C009
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OSA subjects from C009 AERO study who were randomized to the Provent arm and completed the study. All must continue to meet the C009 inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Meir Kryger, MD | Gaylord Sleep Medicine Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaylord Sleep Medicine Research | Wallingford | Connecticut | 06492 | United States | ||
| University of Florida Health Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22003339 | Derived | Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med. 2011 Oct 15;7(5):449-53B. doi: 10.5664/JCSM.1304. |
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| Gainesville |
| Florida |
| 32610-0225 |
| United States |
| Sleep Disorders Center of Georgia | Atlanta | Georgia | 30342 | United States |
| Suburban Lung Associates | Elk Grove Village | Illinois | 60007 | United States |
| Kentucky Research Group | Louisville | Kentucky | 40217 | United States |
| Sleep HealthCenters | Brighton | Massachusetts | 02135 | United States |
| Wayne State University Harper Univ. Hospital | Detroit | Michigan | 48201 | United States |
| Borgess Research | Kalamazoo | Michigan | 49024 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Luke's Hospital Sleep Medicine & Research Center | Chesterfield | Missouri | 63001 | United States |
| The Corvallis Clinic | Corvallis | Oregon | 97330 | 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 |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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