Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorNyxoah Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
Treatment groups
229 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov