🏛️ Verified NIH Record • Updated 2026-06-18
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation (NCT07331285)
🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Nyxoah Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: PharmaDev Clinical Research Institute, LLC — Miami, Florida
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- PharmaDev Clinical Research Institute, LLC — Miami, Florida
- Nyxoah, Inc — Summit, New Jersey
📞 Contact the Study Coordinator
Phone: (908) 263-0228
Email: clinical.studies@nyxoah.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Obstructive Sleep Apnea
- RPMO2 Oximeter Accuracy During Sleep 1 Trial — Dallas, Texas
- Validation of Sleep Questionnaires in the Down Syndrome Population — Portland, Oregon
- 3D Printer Modified CPAP Mask for Obstructive Sleep Apnea — Boston, Massachusetts
- Breathing Training for Improving Cardiovascular Health in Older Adults With Sleep Apnea — Tucson, Arizona
- Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation — Memphis, Tennessee
- Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC) — New York, New York
Explore by condition: All Obstructive Sleep Apnea clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.