Active, not recruitingNo phase
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
Key facts
- Who runs it
- Nyxoah S.A.
- Where
- Belgium, France, Germany, Netherlands, and Switzerland19 sites in 5 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 110 people, planned
- Started
- 1 Sept 2019
- Expected to end
- Oct 2030
- Type of study
- Interventional
- Treatments tested
- Genio® system therapy
- Record updated
- 4 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture
- Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment
- Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing
- Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA
- Life expectancy < 12 months
- Participation in another clinical study (excluding registries) during the study period (3 years)
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Genio® system therapyTreatment being tested
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults.
- Record updated
- 4 March 2026