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Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.
The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)
Safety and efficacy will be evaluated at Month 7, and again at Month 13.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13 |
|
| Control | Other | HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal Nerve Stimulation | Device | Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of response to therapy when compared to no therapy for 6 months | The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7. | Month 1 through Month 7 |
| Rate of all serious adverse device/procedure related events from time of implant through month 7 | The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC). | Month 1 through Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Oxygen Desaturation Index (Efficacy) | Baseline through Month 7 | |
| Change in Functional Outcomes of Sleep Questionnaire (Efficacy | Baseline through Month 7 | |
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Abbreviated: Additional criteria may apply:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Malhotra, MD | UCSD Pulmonary and Critical Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Banner Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008810 | Derived | Malhotra A, Schwartz AR, Lovett E, Juran N, Nguyen SA, Barrera JE, Bogan RK, Mickelson SA, Boghara H, Miller M, Jacobowitz O; OSPREY Investigators. Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in the OSPREY Study : A Randomized Controlled Trial. Ann Intern Med. 2026 Jun;179(6):812-822. doi: 10.7326/ANNALS-25-04414. Epub 2026 Apr 21. | |
| 35613672 |
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All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13.
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PSG results are masked from the Investigator and Outcomes Assessor.
| Change in Epworth Sleepiness Scale (Efficacy) |
| Baseline through Month 7 |
| Change in EQ-5D (Efficacy) | Baseline through Month 7 |
| Change in PROMIS SDI/SRI (Efficacy) | Baseline through Month 7 |
| Change in SF-36 (Efficacy) | Baseline through Month 7 |
| Change in CGI-S/CGI-I (Efficacy) | Baseline through Month 7 |
| Descriptive analysis of all reported Adverse Events (Safety) | Consent through Month 7 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| Sacramento Ent | Roseville | California | 95661 | United States |
| Paul Schalch Lepe, Md/Silenso Clinic | San Diego | California | 92130 | United States |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33126 | United States |
| Morton Plant Mease Health Care | Safety Harbor | Florida | 34695 | United States |
| Advanced Ent Associates | Atlanta | Georgia | 30342 | United States |
| Norton Healthcare | Louisville | Kentucky | 40218 | United States |
| Alivation Research Llc | Lincoln | Nebraska | 68526 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College | New York | New York | 10024 | United States |
| Raleigh Neurology Associates, Pa | Raleigh | North Carolina | 27607 | United States |
| Penn State Health | Hershey | Pennsylvania | 17033 | United States |
| Philadelphia Ear, Nose and Throat Associates | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Bogan Sleep Consultants, Llc | Columbia | South Carolina | 29201 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Epic Medical Research | Red Oak | Texas | 75154 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, Malhotra A. Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. Contemp Clin Trials. 2022 Aug;119:106804. doi: 10.1016/j.cct.2022.106804. Epub 2022 May 22. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001049 | Apnea |
| D012891 | Sleep Apnea Syndromes |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012135 | Respiratory Sounds |
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