NCT07331285 Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
| NCT ID | NCT07331285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nyxoah Inc. |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 229 participants |
| Start Date | 2026-06 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 229 participants in total. It began in 2026-06 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 3. Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events/hr. 4. Patients with Complete Concentric Collapse (CCC) at the soft palate level.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07331285 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07331285 currently recruiting?
Yes, NCT07331285 is actively recruiting participants. Contact the research team at clinical.studies@nyxoah.com for enrollment information.
Where is the NCT07331285 trial being conducted?
This trial is being conducted at Miami, United States, Summit, United States.
Who is sponsoring the NCT07331285 clinical trial?
NCT07331285 is sponsored by Nyxoah Inc.. The trial plans to enroll 229 participants.