Trial Summary
What is the purpose of this trial?A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
Eligibility Criteria
This trial is for adults with moderate to severe obstructive sleep apnea who haven't had success with or can't tolerate positive airway pressure treatments. Participants should have a certain body mass index (BMI) and be able to give informed consent. Those with other untreated sleep disorders or conditions that make surgery or anesthesia risky cannot join.Inclusion Criteria
I likely have moderate to severe sleep apnea based on my medical history.
I am willing and able to agree to the study's procedures.
I cannot or will not use PAP treatments for my condition.
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Exclusion Criteria
I have health conditions that make surgery or anesthesia risky for me.
I have sleep disorders other than OSA that are not well-managed.
Participant Groups
The study is evaluating the safety and effectiveness of the Genio system, which stimulates both sides of the hypoglossal nerve as a treatment for obstructive sleep apnea. It's conducted across multiple centers where participants will receive this new intervention.
1Treatment groups
Experimental Treatment
Group I: Genio TherapyExperimental Treatment1 Intervention
The Genio™ system is an implantable neurostimulation system comprised of one implanted device
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harvard/ Massachusetts Eye & EarBoston, MA
Ohio Sleep Medicine InstituteDublin, OH
The University of Tennessee Health Science Center- Dept. of OtolaryngologyMemphis, TN
Vanderbilt University Medical CenterNashville, TN
More Trial Locations
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Who Is Running the Clinical Trial?
Nyxoah S.A.Lead Sponsor
Nyxoah Inc.Industry Sponsor
Nyxoah, Inc.Collaborator