Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT07303452

Run by

Restera, Inc.

People needed

20

Starts

2025-12-01

Expected to finish

2029-05-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Pregnancy or breast-feeding
• Significant upper airway anatomic abnormalities
• Significant positionally-dependent OSA
• Participants taking medications that may alter body weight

Where it is running

• University of Western Australia — Perth, Australia (enrolling)

Full record on ClinicalTrials.gov

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