New implant zaps nerve to treat sleep apnea without CPAP

NCT ID NCT05592002

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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