A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
← catalyst calendarNCT04031040 · readout in 72 d
Sponsored by Nyxoah S.A. (industry) · NYXH.BR — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
110estimated
Sites
19
Countries
Belgium, France, Germany +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-09-01 | actual | When the study began enrolling |
| Primary completion | 2026-10-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2019-07-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Obstructive Sleep Apnea
Intervention
- Device: Genio® system therapy
Primary outcomes
what the primary-completion date above is the date OFIncidence of device-related Serious Adverse Events (SADEs)
measured 12 months post-surgery
Change in Apnea-Hypopnea Index from baseline
measured 12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
measured 12 months post-surgery
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