Trials / Active Not Recruiting
Active Not RecruitingNCT03868618
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- Sponsor
- Nyxoah S.A. · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Genio™ system | The Genio™ device is a permanent implant. It is implanted in the chin area and delivers stimulation to both hypoglossal nerve branches (i.e., the left and right branches). The implant does not include a battery or an embedded software and is externally powered. |
Timeline
- Start date
- 2020-10-14
- Primary completion
- 2024-02-20
- Completion
- 2028-02-01
- First posted
- 2019-03-11
- Last updated
- 2026-04-14
Locations
21 sites across 4 countries: United States, Australia, Belgium, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03868618. Inclusion in this directory is not an endorsement.