A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Genio(TM) system therapy
- Registration Number
- NCT04031040
- Lead Sponsor
- Nyxoah S.A.
- Brief Summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.
- Detailed Description
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Body Mass Index (BMI) < 35 kg/m2
- AHI between 15 to 65 events/hour documented by a PSG during the screening phase.
- Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
- Night shift worker
- Significant comorbidities that contraindicates surgery
- Life expectancy < 12 months
- Participation in another clinical study (excluding registries) during the study period (3 years).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Genio(TM) system therapy Genio(TM) 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.
- Primary Outcome Measures
Name Time Method Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) 12 months post-surgery Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) reported during the study
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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
🇧🇪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
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
🇫🇷Paris, France
CEREVES Paris Jean Jaurès - Centre du sommeil
🇫🇷Paris, France
Clinique Beau-Soleil
🇫🇷Montpellier, France
CHU - Poitiers
🇫🇷Poitiers, 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
Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin
🇩🇪Berlin, 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
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
🇩🇪Wuppertal, Germany
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
🇨🇭Liestal, Switzerland
Universitair Ziekenhuis Antwerpen
🇧🇪Antwerp, Belgium
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands