Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Australia
The Wollongong Hospital
RECRUITING
Wollongong
Contact Information
Primary
Professor Stuart MacKay FRACS
reception@illawarraent.com.au
+61 2 4226 1055
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2029-06
Participants
Target number of participants: 30
Treatments
Experimental: XII Medical HGNS System
Participants receiving HGNS using the XII Medical System
Related Therapeutic Areas
Sponsors
Leads: XII Medical