RecruitingNCT07331285
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
Sponsor
Nyxoah Inc.
Enrollment
229 participants
Start Date
Jun 1, 2026
Study Type
OBSERVATIONAL
Conditions
Summary
The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
Eligibility
Min Age: 22 Years
Plain Language Summary
Simplified for easier understanding
This clinical trial is studying a medical device called This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1 for people with obstructive sleep apnea. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 22 Years and older.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICEThis is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
Genio® System 2.1
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07331285
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