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The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THN Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aura6000 System | Device | The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline. | 3 and 12 months post-implant | |
| Adverse events and Serious Adverse events peri and post-operatively | 3 and 12 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline. | 3 and 12 months post-operative | |
| Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rodenstein, MD | Clinique Univ. Saint-Luc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Univ. Saint-Luc | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22599356 | Derived | Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17. |
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|
| 3 and 12 months post-implantation |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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