Restera Serene system for adults with obstructive sleep apnea
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.
This trial will test whether a small implanted system that places electrodes near the hypoglossal nerve and ansa cervicalis can safely reduce obstructive sleep apnea in adults who have not tolerated, failed, or refused CPAP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Restera, Inc. Industry-sponsored |
| Locations | 1 site (Perth) |
| Trial ID | NCT07303452 on ClinicalTrials.gov |
What this trial studies
The Restera Serene system is a multi-center proof-of-concept study that uses percutaneously placed electrode arrays to deliver neurostimulation to the hypoglossal nerve and the ansa cervicalis. Adults with moderate-to-severe OSA (AHI 15–65) and BMI ≤32 who have not tolerated, failed, or refused positive airway pressure are eligible, while pregnant people, those with major upper-airway anatomic abnormalities, positional OSA, or on weight-altering medications are excluded. The trial will collect chronic sleep-related data after implantation to characterize safety, device performance, and impact on sleep metrics. Follow-up visits will monitor adverse events and changes in apnea severity and sleep quality.
Who should consider this trial
Good fit: Adults with obstructive sleep apnea (AHI 15–65) and BMI ≤32 kg/m2 who have not tolerated, failed, or refused CPAP are the intended candidates.
Not a fit: People who are pregnant, have significant upper-airway anatomic abnormalities, predominantly positional OSA, or who take medications that alter body weight are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the device could reduce apnea events and improve sleep quality and daytime symptoms for adults who cannot use CPAP.
How similar studies have performed: Hypoglossal nerve stimulation has shown benefit in prior trials, but percutaneous dual-site stimulation including the ansa cervicalis is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Perth
- University of Western Australia — Perth, Australia (Recruiting)
Study contacts
- Study coordinator: Tim Fayram
- Email: tfayram@resterasleep.com
- Phone: 408-612-7570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.