RecruitingObstructive Sleep Apnea
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
Eligible age
22+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Nyxoah Inc.
You may qualify if…
- ✓ 1. Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or equal to 65, measured on a full-night PSG performed no earlier than 2 years prior to enrollment (AHI4 and ODI4 available).
- ✓ 2. Be adults 22 years of age and older.
- ✓ 3. Have been confirmed to have failed, not tolerated, or be ineligible to be treated with current standard of care treatments for moderate to severe OSA.
- ✓ 4. Have pursued insurance pre-authorization for Genio® Therapy, recognizing that pre-authorization does not ensure payment, or demonstrate willingness to assume any out-of-pocket costs. The sponsor will not be responsible for treatment-related charges.
- ✓ 5. Agree to participate in the study and voluntarily sign and date an informed consent form.
- ✓ 6. Be willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits, evaluation procedures and questionnaires for the whole duration of the trial.
- ✓ 7. Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment.
You may not qualify if…
- ✕ 1. Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
- ✕ 2. Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
- ✕ 3. Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1.
- ✕ 4. Women who are pregnant, planning to become pregnant or breastfeeding.
- ✕ 5. Any condition or procedure that has compromised neurological control of the upper airway.
- ✕ 6. Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:
- ✕ 1. Patients below 22 or above 75 years of age.
- ✕ 2. Patients with a Body Mass Index (BMI) above 32 kg/m2.
Where it's recruiting
Florida
Miami
New Jersey
Summit
Source: ClinicalTrials.gov · NCT07331285 · last updated 2026-06-22