Genio® system therapy: Hypoglossal nerve stimulation system
Study summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Body Mass Index (BMI) \< 35 kg/m2
* 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:
* Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment;
* 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).
Primary outcome measure(s)
Incidence of device-related Serious Adverse Events (SADEs) — 12 months post-surgery Incidence of device-related Serious Adverse Events (SADEs)
Change in Apnea-Hypopnea Index from baseline — 12 months post-surgery Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire — 12 months post-surgery Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
Trial sites (19)
Facility
City
Region
Status
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Antwerp
Belgium
Universitair Ziekenhuis Antwerpen
Antwerp
Belgium
CHU - Angers
Angers
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
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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