A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea

• 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.

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-21
• Study First Posted: 2019-07-24
• Study Start: 2019-09-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-26
• Primary Completion: 2022-09-01
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 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)
Change in Apnea-Hypopnea Index from baseline	12 months post-surgery	Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab

Trial Locations

Locations (23)

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

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