Taking peopleNo phase
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
Key facts
- Who runs it
- Restera, Inc.
- Where
- Australia1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- Dec 2025
- Expected to end
- May 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Neurostimulation
- Record updated
- 24 December 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Participants taking medications that may alter body weight
- Pregnancy or breast-feeding
- Significant upper airway anatomic abnormalities
- Significant positionally-dependent OSA
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Single TargetTreatment being tested
Treatment: Neurostimulation
- Dual TargetTreatment being tested
Treatment: Neurostimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Record updated
- 24 December 2025