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Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Sponsor: LivaNova
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.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-07-27
Completion Date
2025-10-30
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
Hypoglossal Nerve Stimulation
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Locations (20)
University of Alabama At Birmingham
Birmingham, Alabama, United States
Banner Health
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Sacramento Ent
Roseville, California, United States
Paul Schalch Lepe, Md/Silenso Clinic
San Diego, California, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
Morton Plant Mease Health Care
Safety Harbor, Florida, United States
Advanced Ent Associates
Atlanta, Georgia, United States
Norton Healthcare
Louisville, Kentucky, 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
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, United States
Penn State Health
Hershey, Pennsylvania, United States
Philadelphia Ear, Nose and Throat Associates
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bogan Sleep Consultants, Llc
Columbia, South Carolina, United States
Houston Methodist
Houston, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
University of Utah
Salt Lake City, Utah, United States