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Clinical Trials in Australia / NCT07303452
Recruiting Not applicable

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

NCT07303452 · tracked via the Priya Life Science Australia tracker
Sponsor
Restera, Inc
Phase
Not applicable
Started
2025-12
Last updated
2025-12-24

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Neurostimulation

Neurostimulation: Neurostimulation via Restera Serene System

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Safety of the Restera Serene System — 6 months
    Incidence of device and/or procedure-related serious adverse events
  • Effectiveness of the Restera Serene System — 6 months
    Change from baseline in the Apnea-Hypopnea Index

Trial sites (1)

FacilityCityRegionStatus
University of Western Australia Perth Australia Recruiting

Other trials for the same condition

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy Active, not recruiting
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM) Active, not recruiting
CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects Starting soon
Post Market Clinical Follow up of ResMed Mask Systems Recruiting
Exploration of Current and New Technologies for Accuracy of Diagnosing OSA Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303452 on ClinicalTrials.gov ↗ ← All trials in Australia