Actively Recruiting
Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Led by XII Medical · Updated on 2025-11-18
30
Participants Needed
5
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Mass Index (BMI) C= 32 kg/m2
- Apnea-Hypopnea Index (AHI) of 15-50 events per hour
- Central plus mixed apnea index C= 25%
- Participants who have not tolerated, failed, or refused positive airway pressure (PAP) treatment
You will not qualify if you...
- Pregnancy or breast-feeding
- Significant upper airway anatomic abnormalities
- Hypoglossal nerve weakness
- Central sleep apnea condition
- Significant positionally-dependent obstructive sleep apnea
- Complete concentric patterns of soft palate collapse on drug-induced sleep endoscopy (DISE)
- Untreated non-OSA sleep disorders
- Significant co-morbidities or prior surgeries contraindicating surgery or general anesthesia
- Use of medications that may alter consciousness, breathing patterns, or sleep architecture
- Participants currently taking glucagon-like peptide-1 (GLP-1) medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Canberra ENT
Canberra, Australian Capital Territory, Australia
Actively Recruiting
2
Westmead Hospital / Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Actively Recruiting
3
The Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
4
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Actively Recruiting
5
Perth Head & Neck Surgery
Perth, Western Australia, Australia
Actively Recruiting
Research Team
P
Professor Stuart MacKay FRACS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here