Clinical Trial

Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation

Study acronym: BREATHE
Recruiting
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-23
Trial Details
NCT Number NCT07331285
Lead Sponsor Nyxoah Inc.
Conditions Obstructive Sleep Apnea
Enrollment 229 participants
Start Date 2026-06
Primary Completion 2028-10 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-22