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

Recruiting now

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT07331285

Run by

Nyxoah Inc.

People needed

229

Starts

2026-06-01

Expected to finish

2032-10-01

Last updated by the study team

2026-06-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Be adults 22 years of age and older.
• 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.
• 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.
• Agree to participate in the study and voluntarily sign and date an informed consent form.
• 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.
• Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment.

You may not qualify if…

• Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.
• Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.
• Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1.
• Women who are pregnant, planning to become pregnant or breastfeeding.
• Any condition or procedure that has compromised neurological control of the upper airway.
• Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:
• Patients below 22 or above 75 years of age.
• Patients with a Body Mass Index (BMI) above 32 kg/m2.
• Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events/hr.
• Patients with Complete Concentric Collapse (CCC) at the soft palate level.

Where it is running

• PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States (enrolling)
• Nyxoah, Inc — Summit, New Jersey, United States

Full record on ClinicalTrials.gov

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