Plain-English translation of NCT07331285 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This trial is testing the Genio System 2.1, a surgically implanted device designed to help people with obstructive sleep apnea breathe better during sleep. The study will follow about 229 people for up to 5 years after they receive the implant to see how well the treatment works in real-world patients and whether it's safe to use long-term.
Sleep apnea can be life-threatening if left untreated, but many patients struggle with or cannot use standard treatments like CPAP machines. This trial exists to see whether this new implanted device offers a better option for people who have tried other treatments without success.
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If accepted, you would have surgery to implant the Genio System 2.1 device, then return 8 weeks later to activate it. After that, you would attend follow-up appointments at 6, 9, 12 months, and every 6 months for up to 5 years. During these visits, doctors will check how well the device is working, make any needed adjustments, and ask you to complete questionnaires about your sleep and quality of life.
AI-generated summary from trial data · Jul 8, 2026 · Not medical advice
United States
Sponsor
Nyxoah Inc.
Enrollment target
~229 participants
Started
June 2026
Primary completion
October 2028
Age range
22 Years and older
Last updated on clinicaltrials.gov in June 2026.
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Central contact
Lorin Pétré
Nyxoah Inc.
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