Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neurostimulation.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Device Neurostimulation
Neurostimulation via Restera Serene System
Primary outcome measures
- Safety of the Restera Serene System [Time frame: 6 months]
- Effectiveness of the Restera Serene System [Time frame: 6 months]
Secondary outcome measures (2)
- Long-term Safety of the Restera Serene System [Time frame: 36 months]
- Long-term Effectiveness of the Restera Serene System [Time frame: 36 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- University of Western Australia — Perth
Identifiers
NCT: NCT07303452 · IM-010