A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
NCT ID: NCT04031040
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
110 participants
INTERVENTIONAL
2019-09-01
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Genio® system therapy
Following activation of the Genio® system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.
Genio® system therapy
Hypoglossal nerve stimulation system
Interventions
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Genio® system therapy
Hypoglossal nerve stimulation system
Eligibility Criteria
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Inclusion Criteria
* AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase.
* Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
Exclusion Criteria
* Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture;
* Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA;
* Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing;
* Life expectancy \< 12 months;
* Participation in another clinical study (excluding registries) during the study period (3 years).
18 Years
ALL
No
Sponsors
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Nyxoah S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Joachim T. Maurer, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik für HNO-Heilkunde, Mannheim
Locations
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Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Antwerp, , Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
CHU - Angers
Angers, , France
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Hôpital Henri-Mondor AP-HP
Créteil, , France
Hôpital Privé La Louvière
Lille, , France
Clinique Beau-Soleil
Montpellier, , France
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
Paris, , France
CEREVES Paris Jean Jaurès - Centre du sommeil
Paris, , France
Hôpital Tenon AP-HP
Paris, , France
CHU - Poitiers
Poitiers, , France
Clinique Mutualiste de la Sagesse
Rennes, , France
Polyclinique Saint Laurent
Rennes, , France
CHU Toulouse
Toulouse, , France
Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
Hamburg, , Germany
HNO-Klinik des Universitätsklinikums Jena
Jena, , Germany
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
Mannheim, , Germany
Klinikum rechts der Isar der TU München
München, , Germany
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
Wuppertal, , Germany
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
Liestal, , Switzerland
Countries
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Other Identifiers
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CL-GEN-002068
Identifier Type: -
Identifier Source: org_study_id