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The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HGNS System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGNS Treatment | Device | The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline | 6 months post-implant | |
| Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline | 6 months post-implant | |
| The frequency of serious adverse events. | One month post-implant. | |
| The frequency of serious adverse events. | 3 months post-implant. | |
| The frequency of serious adverse events. | 6 months post-implant. |
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Eligibility Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jon Freeman, PhD | Clinilabs, Inc. West Side ENT, NY, NY | Principal Investigator |
| Tod Huntley, MD | Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN | Principal Investigator |
| Con Iber, MD | Dept of Neurology, University of Minnesota | Principal Investigator |
| Eric Kezirian, MD | University of Califoprnia - San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Saint Vincent Hospital |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Clinilabs, Inc. | New York | New York | 10019 | United States |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |