Clinical trial NCT04031040: A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults
Official title: A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Nyxoah S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs)
timeFrame: 12 months post-surgery
measure: Change in Apnea-Hypopnea Index from baseline
timeFrame: 12 months post-surgery
measure: Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
timeFrame: 12 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Angers
country: France
facility: CHU - Angers
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Créteil
country: France
facility: Hôpital Henri-Mondor AP-HP
city: Lille
country: France
facility: Hôpital Privé La Louvière
city: Montpellier
country: France
facility: Clinique Beau-Soleil
city: Paris
country: France
facility: Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
city: Paris
country: France
facility: CEREVES Paris Jean Jaurès - Centre du sommeil
city: Paris
country: France
facility: Hôpital Tenon AP-HP
city: Poitiers
country: France
facility: CHU - Poitiers
city: Rennes
country: France
facility: Clinique Mutualiste de la Sagesse
city: Rennes
country: France
facility: Polyclinique Saint Laurent
city: Toulouse
country: France
facility: CHU Toulouse
city: Berlin
country: Germany
facility: Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
city: Jena
country: Germany
facility: HNO-Klinik des Universitätsklinikums Jena
city: Mannheim
country: Germany
facility: Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Regensburg
country: Germany
facility: Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
Study officials:
affiliation: Klinik für HNO-Heilkunde, Mannheim
name: Joachim T. Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References: