Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Status: Active_not_recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• Diagnosis of moderate to severe OSA
• Declines to use or does not tolerate PAP therapy
Locations
United States
Alabama
University of Alabama At Birmingham
Birmingham
Arizona
Banner Health
Phoenix
University of Arizona
Tucson
California
Sacramento Ent
Roseville
Paul Schalch Lepe, Md/Silenso Clinic
San Diego
Florida
Sleep Medicine Specialists of South Florida
Miami
Morton Plant Mease Health Care
Safety Harbor
Georgia
Advanced Ent Associates
Atlanta
Kentucky
Norton Healthcare
Louisville
North Carolina
Raleigh Neurology Associates, Pa
Raleigh
Nebraska
Alivation Research Llc
Lincoln
New Jersey
Hackensack University Medical Center
Hackensack
New York
Weill Cornell Medical College
New York
Pennsylvania
Penn State Health
Hershey
Philadelphia Ear, Nose and Throat Associates
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Bogan Sleep Consultants, Llc
Columbia
Texas
Houston Methodist
Houston
Epic Medical Research
Red Oak
Utah
University of Utah
Salt Lake City
Time Frame
Start Date: 2021-07-27
Completion Date: 2025-04
Participants
Target number of participants: 150
Treatments
Active_comparator: Active
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
Other: Control
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
Authors
Related Therapeutic Areas
Sponsors
Leads: LivaNova