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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Body Mass Index (BMI) ≤ 32 kg/m2
• AHI between 15-65 events/hour
• Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
Locations
Other Locations
Australia
University of Western Australia
RECRUITING
Perth
Contact Information
Primary
Tim Fayram
tfayram@resterasleep.com
408-612-7570
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2029-05
Participants
Target number of participants: 20
Treatments
Experimental: Single Target
Experimental: Dual Target
Related Therapeutic Areas
Sponsors
Leads: Restera, Inc.