Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
Recruiting
Observational Study
Obstructive Sleep Apnea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
229 (estimated)
Sponsor
Nyxoah Inc. · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe obstructive sleep apnea who have not tolerated or failed standard treatments. Participants will be required to sign consent and complete various assessments throughout the trial.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 22 years old.
I have been diagnosed with moderate to severe obstructive sleep apnea.
My apnea-hypopnea index (AHI) is between 15 and 65.
I have pursued insurance for Genio® Therapy or am willing to pay out-of-pocket.
I agree to participate in the study and sign the consent form.
I can comply with all study requirements and follow-up visits.
I have had a Drug-Induced Sleep Endoscopy in the last 2 years.
You may not be able to join if
I have a combined central and mixed apnea-hypopnea index of 25% or more.
I have any medical issue that would interfere with the Genio® Therapy.
I have an implantable device that may interact with the Genio® System.
I am pregnant, planning to become pregnant, or breastfeeding.
I have a condition that affects control of my upper airway.
I am under 22 or over 75 years old.
I have a Body Mass Index (BMI) over 32 kg/m2.
I have an AHI below 15 or over 65.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 fa…
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.
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