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Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
Sponsor: Restera, Inc.
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-12
Completion Date
2029-05
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
Neurostimulation
Neurostimulation via Restera Serene System
Locations (1)
University of Western Australia
Perth, Australia