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RECRUITING
NCT07049744
NA

Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

Sponsor: XII Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-06-24

Completion Date

2029-06

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DEVICE

XII 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