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