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.
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At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
229 (estimated)
Sponsor
Nyxoah Inc. · Industry
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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.

Trial Locations
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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…
Contacts

Lorin Pétré

+1 (908) 263-0228

clinical.studies@nyxoah.com

CONTACT

Alicia Castonguay

clinical.studies@nyxoah.com

CONTACT