New implant zaps nerve to treat sleep apnea without CPAP

NCT ID NCT05592002

Ongoing Disease control Sponsor: Nyxoah S.A. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a device called the Genio® System, which is implanted under the chin and stimulates a nerve to keep the airway open during sleep. It is for people with obstructive sleep apnea who have not been helped by CPAP machines and have a specific type of airway collapse. The study will track 124 participants for 12 months to see if the device reduces breathing pauses and improves oxygen levels.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Genio® dual-sided hypoglossal nerve stimulation system (implantable device)
What this could lead to: If it works, this could offer a new treatment option for people with obstructive sleep apnea who cannot use a CPAP machine, especially those with a specific type of airway collapse.
What could go wrong: This is an early-stage study with no control group, so results may not prove the device works better than no treatment or other options. The device requires surgery, and long-term safety and effectiveness are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SLEEP APNEA, OBSTRUCTIVE

Contacts and locations

Locations

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States
Center for ENT and Allergy, PC Ascension Medical Group

Carmel, Indiana, 46032, United States
Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States
ENT and Allergy Associates of Florida, LLC

Boca Raton, Florida, 33487, United States
Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States
Hospital of the University Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Massachusetts Eye & Ear

Boston, Massachusetts, 02114, United States
PharmaDev Clinical Research Institute,

Miami, Florida, 33176, United States
Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107, United States
University of Iowa Institute for Clinical & Translational Science

Iowa City, Iowa, 52242, United States
University of Kansas

Kansas City, Kansas, 66160, United States
University of Miami

Miami, Florida, 33136, United States
University of Rochester

Rochester, New York, 14627, United States
University of South Florida

Tampa, Florida, 33620, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.