NCT07303452 Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
| NCT ID | NCT07303452 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Restera, Inc. |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Pregnancy or breast-feeding * Significant upper airway anatomic abnormalities * Significant positionally-dependent OSA * Participants taking medications that may alter body weight
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07303452 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07303452 currently recruiting?
Yes, NCT07303452 is actively recruiting participants. Contact the research team at tfayram@resterasleep.com for enrollment information.
Where is the NCT07303452 trial being conducted?
This trial is being conducted at Perth, Australia.
Who is sponsoring the NCT07303452 clinical trial?
NCT07303452 is sponsored by Restera, Inc.. The trial plans to enroll 20 participants.