Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

NCT07049744 · tracked via the Priya Life Science Australia tracker

Sponsor

XII Medical

Phase

Not applicable

Started

2025-06-24

Last updated

2026-07-30

Condition(s) studied

Obstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

XII Medical HGNS System

XII Medical HGNS System: XII Medical HGNS System

Study 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

Sex

ALL

Min age

21 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Body Mass Index (BMI) ≤ 32 kg/m2 * AHI of 15-50 events/hour * Central + mixed apnea index ≤ 25% * Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) Exclusion Criteria: * Pregnancy or breast-feeding. * Significant upper airway anatomic abnormalities * Hypoglossal nerve weakness * Central sleep apnoea condition * Significant positionally-dependent OSA. * Complete concentric patterns of soft palate collapse on DISE * Inadequately treated non-OSA sleep disorder(s). * Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia * Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture * Participants on a GLP-1

Primary outcome measure(s)

Safety of the XII Medical HGNS System — Six months post-implantation
Assessment of serious adverse device events

Trial sites (6)

Facility	City	Region	Status
Canberra ENT	Canberra	Australian Capital Territory	Recruiting
Woolcock Institute Of Medical Research	Sydney	New South Wales	Recruiting
Westmead Hospital / Chris O'Brien Lifehouse	Sydney	New South Wales	Recruiting
The Wollongong Hospital	Wollongong	New South Wales	Recruiting
Princess Alexandra Hospital	Brisbane	Queensland	Recruiting
Perth Head & Neck Surgery	Perth	Western Australia	Recruiting

Other trials for the same condition

Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea Recruiting

Study of Min-Max APAP Recommender Tool Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07049744 on ClinicalTrials.gov ↗ ← All trials in Australia