Active — Not RecruitingNot Applicable

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

Belgium, France, Germany110 participantsStarted 2019-09-01

Plain-language 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 post-surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of device-related Serious Adverse Events (SADEs)

Timeframe: 12 months post-surgery

Change in Apnea-Hypopnea Index from baseline

Timeframe: 12 months post-surgery

Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire

Timeframe: 12 months post-surgery

Trial details

NCT IDNCT04031040

SponsorNyxoah S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-30

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.