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The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aura6000 THN Therapy | Experimental | The aura6000 THN system will be implanted and activated for nightly therapy during sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aura6000 THN 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 |
|---|---|---|
| Reduction in Apnea-Hypopnea Index (AHI) | Change from baseline in AHI measured through in-lab polysomnography (PSG). | 3, 6, and 12 months post implant |
| Reduction in Oxygen Desaturation Index (ODI) | Change from baseline in ODI measured through in-lab polysomnography (PSG). | 3, 6, and 12 months post implant |
| Freedom from Serious Adverse Events (SAE) | Adverse events and Serious Adverse events post-operatively | 1 and 12 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in sleep fragmentation | Mean change in microarousal index as compared to baseline. | 3, 6, and 12 months post-implant |
| Improvement in SAQLI | Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rodenstein, MD, PhD | Clinique Univ. Saint-Luc | Principal Investigator |
| Ofer Jacobowitz, MD PhD | Hudson Valley ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Rees Stealy Medical Center | San Diego | California | 92123 | United States | ||
| Porter Adventist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22938390 | Background | Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31. | |
| 22599356 | Background |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D001049 | Apnea |
| D012816 | Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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|
| 3, 6, and 12 months post implant |
| Improvement in ESS | Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline. | 3, 6, and 12 months post implant |
| Denver |
| Colorado |
| 80210 |
| United States |
| Chicago ENT | Chicago | Illinois | 60657 | United States |
| Orange Regional Medical Center | Middletown | New York | 10940 | United States |
| Clinique Univ. Saint-Luc | Brussels | 1200 | Belgium |
| Pitié-Salpêtrière Hospital | Paris | 75013 | France |
| Advanced Sleep Research | Berlin | 10117 | Germany |
| St. Joseph-Stift | Bremen | 28209 | Germany |
| G.B. Morgagni- L. Pierantoni Hospital | Forlì | 47121 | Italy |
| 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. |