Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human S
The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea (OSA).
| Condition(s) | Obstructive Sleep Apnea |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea (OSA). |
| Who can participate | Inclusion Criteria: * Patient is between 21 and ≤70 years of age * Subject has moderate to severe obstructive sleep apnea (defined as apnea-hypopnea index of 15-50 events/hour on baseline/screening polysomnogram) * Subject is intolerant of positive airway pressure therapy (defined as \<2 hours of sleep time with use per night for at least 5 nights per week as measured objectively by evaluation of continuous positive airway pressure (CPAP) machine memory chip and interpreted by the study sleep medicine specialist) * Subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks Exclusion Criteria: * Any evidence that apnea is not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Lead sponsor | Michael Harrison |
| Locations | San Francisco, California, United States |
| Start date | 2015-09 |
| NCT ID | NCT02431507 |
| Official listing | https://clinicaltrials.gov/study/NCT02431507 |