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ACTIVE NOT RECRUITING
NCT04950894
NA

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Sponsor: LivaNova

View on ClinicalTrials.gov

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

Interventions

DEVICE

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