Status: Recruiting
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
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.
Participants needed: 229
Trial details
Age: 22+Biological sex: AllType: ObservationalSponsor: Nyxoah Inc.Updated: Jun 22, 2026Locations: 2
Eligibility criteria
Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or... [+6]
Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 2... [+8]