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Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Sponsor: XII Medical
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
Conditions
Interventions
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