Trials / Recruiting
RecruitingNCT07303452
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
A Multi-center Proof-of-concept Study to Assess the Safety and Effectiveness of the Restera™ Serene™ System When Stimulating the Hypoglossal Nerve Alone or the Hypoglossal Nerve Plus the Ansa Cervicalis Nerve for the Treatment of Obstructive Sleep Apnoea in Adult Participants.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Restera, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Neurostimulation | Neurostimulation via Restera Serene System |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-09-01
- Completion
- 2029-05-01
- First posted
- 2025-12-24
- Last updated
- 2025-12-24
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT07303452. Inclusion in this directory is not an endorsement.