Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Apnea+Hypopnea, Hypopnea, Sleep

In brief

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 facts

Study ID

NCT04950894

Run by

LivaNova

People needed

107

Starts

2022-02-24

Expected to finish

2025-04-23

Last updated by the study team

2026-07-17

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of moderate to severe OSA
• Declines to use or does not tolerate PAP therapy

You may not qualify if…

• Respiratory, cardiac, renal disease or other co-morbid conditions
• BMI > 35 kg/m2
• Specific PSG criteria outlined in the protocol

Where it is running

• University of Alabama At Birmingham — Birmingham, Alabama, 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
• Lankenau Hospital — 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

Full record on ClinicalTrials.gov

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