Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
← catalyst calendarNCT07331285 · readout ≤ 804 d
Sponsored by Nyxoah Inc. (industry) · NYXH.BR — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
229estimated
Sites
2
Country
United States
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 | Jun 2026 | estimated | When the study began enrolling |
| Primary completion | Oct 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-22 | 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: This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1 — also filed as Genio Therapy
Primary outcomes
what the primary-completion date above is the date OFChange in Apnea Hypopnea Index (AHI4%)
measured 12 months
Change in Oxyhemoglobin Desaturation Index (ODI4%)
measured 12 months
Device related SAEs
measured 12 months
Device-related and procedure-related SAEs
measured 12 months
Publications
- PMID 40702817 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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