Actively Recruiting
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
Led by Restera, Inc. · Updated on 2025-12-24
20
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Mass Index (BMI) 64 32 kg/m2
- Apnea-Hypopnea Index (AHI) between 15 and 65 events per hour
- Adults who have not tolerated, have failed, or refused positive airway pressure (PAP) therapy
You will not qualify if you...
- Pregnancy or breast-feeding
- Significant upper airway anatomic abnormalities
- Significant positionally-dependent obstructive sleep apnea
- Taking medications that may alter body weight
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Western Australia
Perth, Australia
Actively Recruiting
Research Team
T
Tim Fayram
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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