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New implant could help sleep apnea sufferers ditch CPAP

NCT ID NCT04031040

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

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

Summary

This study follows 110 adults with moderate to severe obstructive sleep apnea who have the Genio® device implanted. The device stimulates a nerve to keep the airway open during sleep. Researchers will track safety and effectiveness over 5 years, including changes in breathing pauses and quality of life.

What this could mean

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

Active substance
Genio® hypoglossal nerve stimulation device
What this could lead to
If successful, this could provide a long-term treatment option for people with moderate to severe sleep apnea who cannot use standard therapies like CPAP.
What could go wrong
This is a post-market study, so the device is already approved. However, it may not work for everyone, and risks include device-related side effects or the need for ongoing management.

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.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

OBSTRUCTIVE SLEEP APNEA

Contacts and locations

Locations

  • Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie

    Hamburg, 21075, Germany

  • CEREVES Paris Jean Jaurès - Centre du sommeil

    Paris, 75019, France

  • CHU - Angers

    Angers, 49933, France

  • CHU Toulouse

    Toulouse, 31400, France

  • Clinique Beau-Soleil

    Montpellier, 34070, France

  • Clinique Mutualiste de la Sagesse

    Rennes, 35000, France

  • HNO-Klinik des Universitätsklinikums Jena

    Jena, 07747, Germany

  • Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

    Wuppertal, 42283, Germany

  • Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

    Paris, 75018, France

  • Hôpital Henri-Mondor AP-HP

    Créteil, 94010, France

  • Hôpital Privé La Louvière

    Lille, 59800, France

  • Hôpital Tenon AP-HP

    Paris, 75020, France

  • Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

    Liestal, 4410, Switzerland

  • Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum

    Mannheim, 68167, Germany

  • Klinikum rechts der Isar der TU München

    München, 81675, Germany

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1061 AE, Netherlands

  • Polyclinique Saint Laurent

    Rennes, 35700, France

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650, Belgium

  • Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

    Antwerp, 2170, Belgium

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