Clinical Trials in France / NCT04031040
Active, not recruiting
Not applicable
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
NCT04031040 · tracked via the Priya Life Science France tracker
Condition(s) studied
Obstructive Sleep Apnea
Investigational drug(s) / intervention(s)
Genio® system therapy
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
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 | Liestal | Switzerland |
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Official registry record
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.
View NCT04031040 on ClinicalTrials.gov ↗ ← All trials in France