Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
NCT07303452 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-12-24
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
- DEVICE
-
Neurostimulation
Neurostimulation via Restera Serene System
Sponsors & Collaborators
-
Restera, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-31
- Primary Completion
- 2026-09-30
- Completion
- 2029-05-31
Countries
- Australia
Study Locations
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