RecruitingNot ApplicableNCT07303452

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.

Sponsor

Restera, Inc.

Enrollment

20 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Obstructive Sleep Apnea

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Neurostimulation for people with obstructive sleep apnea. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeurostimulation

Neurostimulation via Restera Serene System

Locations(1)

University of Western Australia

Perth, Australia

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NCT07303452

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