Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
- Conditions
- OSAApnea, ObstructiveApneaHypopnea, SleepObstructive Sleep ApneaApnea, Obstructive SleepApnea+Hypopnea
- Interventions
- Device: Hypoglossal Nerve Stimulation
- Registration Number
- NCT04950894
- Lead Sponsor
- LivaNova
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Diagnosis of moderate to severe OSA
- Declines to use or does not tolerate PAP therapy
- Respiratory, cardiac, renal disease or other co-morbid conditions
- BMI > 35 kg/m2
- Specific PSG criteria outlined in the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active Hypoglossal Nerve Stimulation HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13 Control Hypoglossal Nerve Stimulation 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
- Primary Outcome Measures
Name Time Method Rate of all serious adverse device/procedure related events from time of implant through month 7 Month 1 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).
Rate of response to therapy when compared to no therapy for 6 months Month 1 through Month 7 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.
- Secondary Outcome Measures
Name Time Method Change in EQ-5D (Efficacy) Baseline through Month 7 Change in PROMIS SDI/SRI (Efficacy) Baseline through Month 7 Decrease in Oxygen Desaturation Index (Efficacy) Baseline through Month 7 Change in Functional Outcomes of Sleep Questionnaire (Efficacy Baseline through Month 7 Change in Epworth Sleepiness Scale (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
Trial Locations
- Locations (20)
Sacramento Ent
🇺🇸Roseville, California, United States
Advanced Ent Associates
🇺🇸Atlanta, Georgia, United States
Morton Plant Mease Health Care
🇺🇸Safety Harbor, Florida, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Raleigh Neurology Associates, Pa
🇺🇸Raleigh, North Carolina, United States
Penn State Health
🇺🇸Hershey, Pennsylvania, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Philadelphia Ear, Nose and Throat Associates
🇺🇸Philadelphia, Pennsylvania, United States
Epic Medical Research
🇺🇸Red Oak, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Bogan Sleep Consultants, Llc
🇺🇸Columbia, South Carolina, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Alivation Research Llc
🇺🇸Lincoln, Nebraska, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Paul Schalch Lepe, Md/Silenso Clinic
🇺🇸San Diego, California, United States
Sleep Medicine Specialists of South Florida
🇺🇸Miami, Florida, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Banner Health
🇺🇸Phoenix, Arizona, United States