RecruitingNot ApplicableNCT07049744

Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study


Sponsor

XII Medical

Enrollment

30 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this interventional study is to assess the safety and performance of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in people who have moderate to severe Obstructive Sleep Apnea (OSA). Participation in this study involves being implanted with a Neurostimulator which provides electrical stimulation of the hypoglossal nerve (HGN). Participants will receive treatment at home during sleep, and participate in sleep studies to track and record the quality of the sleep. Participants will be monitored over the course of the study.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called XII Medical HGNS System for people with obstructive sleep apnea (osa). The study is currently recruiting participants at 5 locations.

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

DEVICEXII Medical HGNS System

XII Medical HGNS System


Locations(5)

Canberra ENT

Canberra, Australian Capital Territory, Australia

Westmead Hospital / Chris O'Brien Lifehouse

Sydney, New South Wales, Australia

The Wollongong Hospital

Wollongong, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Perth Head & Neck Surgery

Perth, Western Australia, Australia

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NCT07049744


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