New implant aims to silence snoring and save lives

NCT ID NCT07331285

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called the Genio® System for people with moderate to severe obstructive sleep apnea who cannot use CPAP machines. The device is implanted and stimulates the tongue to keep the airway open during sleep. Researchers will track how well it reduces breathing pauses and oxygen drops over five years in 229 adults.

What this could mean

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

Active substance
Genio® System 2.1 (implantable device that stimulates the tongue to keep the airway open during sleep)
What this could lead to
If successful, this could provide a long-term treatment option for people with obstructive sleep apnea who cannot tolerate standard CPAP therapy.
What could go wrong
This is a single-arm study (no comparison group), so results may be less definitive. Risks include device-related side effects or the therapy not working for everyone.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Nyxoah, Inc

    NOT_YET_RECRUITING

    Summit, New Jersey, 07901, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • PharmaDev Clinical Research Institute, LLC

    RECRUITING

    Miami, Florida, 33176, United States

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