NCT07331285

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 229 (estimated)
• Sponsor: Nyxoah Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BREATHE is a multicenter, prospective, single-arm, post-approval study. Following a baseline visit and implantation of the Genio® System 2.1, subjects will be asked to return for a therapy activation visit at approximately 8 weeks post-implant surgery. The subject will have follow-up visits at 6 months, 9 months, 12 months and every 6-months thereafter up to 5 years post-implant surgery. Additional visits (for device titration or other reasons) are per standard of care and at the Investigator's discretion. Endpoints will be assessed at 12, 24, 36, 48 and 60 months.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1	Genio® System 2.1

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-10-01
• Completion: 2032-10-01
• First posted: 2026-01-09
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study