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

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.

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.

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