Language: BG BG
← Back to results
Recruiting Not applicable NCT07303452

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

No applicable phase (e.g. observational)
Conditions: Obstructive Sleep Apnea

Sponsor: Restera, Inc.

trial.available_in: БГ
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.
Who can participate
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
Locations 1
Australia (1)
University of Western Australia
Perth
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.12.2025
Completion date
01.05.2029
Registry ID
NCT07303452
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.