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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
XII Medical HGNS System
Canberra ENT
Canberra, Australian Capital Territory, Australia
RECRUITINGWoolcock Institute Of Medical Research
Sydney, New South Wales, Australia
RECRUITINGWestmead Hospital / Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
RECRUITINGThe Wollongong Hospital
Wollongong, New South Wales, Australia
RECRUITINGPrincess Alexandra Hospital
Brisbane, Queensland, Australia
RECRUITINGPerth Head & Neck Surgery
Perth, Western Australia, Australia
RECRUITINGSafety of the XII Medical HGNS System
Assessment of serious adverse device events
Time frame: Six months post-implantation
Performance of the XII Medical HGNS System
Change from baseline and Responder Rates for the Apnea Hypopnea Index
Time frame: Six months post-implantation
Performance of the XII Medical HGNS System
Change from baseline and Responder Rates for the Oxygen Desaturation Index
Time frame: Six months post-implantation
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