CompletedNo phase
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Key facts
- Where
- Atlanta, Birmingham, Charleston, Columbia, Hackensack, Hershey, Houston, Lincoln, Louisville, Miami, New York, Philadelphia, Raleigh, Red Oak, Roseville, Safety Harbor, Salt Lake City, San Diego, and Tucson, United StatesSee the 19 sites
Where in United States
- Advanced Ent AssociatesAtlanta, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Bogan Sleep Consultants, LLCColumbia, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- Penn State HealthHershey, United StatesNo longer taking part
- Houston MethodistHouston, United StatesNo longer taking part
- Alivation Research, LLCLincoln, United StatesNo longer taking part
- Norton HealthcareLouisville, United StatesNo longer taking part
- Sleep Medicine Specialists of South FloridaMiami, United StatesNo longer taking part
- Weill Cornell Medical CollegeNew York, United StatesNo longer taking part
- Lankenau HospitalPhiladelphia, United StatesNo longer taking part
- Raleigh Neurology Associates PARaleigh, United StatesNo longer taking part
- Epic Medical ResearchRed Oak, United StatesNo longer taking part
- Sacramento EntRoseville, United StatesNo longer taking part
- Morton Plant Mease Health CareSafety Harbor, United StatesNo longer taking part
- University of UtahSalt Lake City, United StatesNo longer taking part
- Paul Schalch Lepe, Md/Silenso ClinicSan Diego, United StatesNo longer taking part
- University of ArizonaTucson, United StatesNo longer taking part
Trial details
- Who runs it
- LivaNova
- Trial code
- NCT04950894
- Record updated
- 17 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Diagnosis of moderate to severe OSA; Declines to use or does not tolerate PAP therapy.
Exclusion: Respiratory, cardiac, renal disease or other co-morbid conditions; BMI > 35 kg/m2; Specific PSG criteria outlined in the protocol.
Abbreviated: Additional criteria may apply:.