Status:
ACTIVE_NOT_RECRUITING
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
Lead Sponsor:
Nyxoah S.A.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04031040
Start Date
September 1 2019
End Date
October 1 2030
Last Update
December 29 2025
Active Locations (21)
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1
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Antwerp, Belgium, 2170
2
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
3
CHU - Angers
Angers, France, 49933
4
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000