TerminatedNot Applicable

BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse

Stopped: The study was terminated due to operational challenges impacting protocol execution across sites.

Australia42 participantsStarted 2019-01-10

Plain-language summary

The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

Who can participate

Age range

21 Years – 75 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: * Man or woman between 21 and 75 years of age * Body mass index (BMI) ≤ 32 kg/m2 * Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour * Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments. Exclusion Criteria: * Unable or incapable of providing informed written consent * Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

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 serious device-related adverse events recorded during the study

Timeframe: 6 months

Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Timeframe: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Trial details

NCT IDNCT03763682

SponsorNyxoah S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-28

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials