Nerve Stimulation Device for Obstructive Sleep Apnea
(DREAM Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byTucker Woodson, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nyxoah S.A.

No Placebo Group

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.

See 1 more

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.

Treatment Details

Interventions

Genio™ system (Hypoglossal Nerve Stimulation)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Genio TherapyExperimental Treatment1 Intervention

The Genio™ system is an implantable neurostimulation system comprised of one implanted device