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The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HGNS Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGNS Treatment | Device | The Apnex Hypoglossal Nerve Stimulation (HGNS) System 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 | |
| Adverse event profile interoperatively, perioperatively, and long term post implant | 1, 3, 6, 12, 24, and 36 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline | 6 months post-implant |
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Eligibility Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Maree Barnes, MD | Institute for Breathing and Sleep, Austin Health | Principal Investigator |
| David Hillman, MD | West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital | Principal Investigator |
| Doug McEvoy, MD | Adelaide Institute for Sleep Health, Repatriation General Hospital | Principal Investigator |
| John Wheatley, MD | Westmead Hospital Dept of Respiratory Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22043118 | Result | Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380. |
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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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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |