Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
BEAT OSA
Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
1 other identifier
interventional
30
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2025
CompletedFirst Submitted
Initial submission to the registry
June 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
November 18, 2025
November 1, 2025
1.4 years
June 25, 2025
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of the XII Medical HGNS System
Assessment of serious adverse device events
Six months post-implantation
Secondary Outcomes (2)
Performance of the XII Medical HGNS System
Six months post-implantation
Performance of the XII Medical HGNS System
Six months post-implantation
Study Arms (1)
XII Medical HGNS System
EXPERIMENTALParticipants receiving HGNS using the XII Medical System
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XII Medicallead
Study Sites (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, 2500, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Perth Head & Neck Surgery
Perth, Western Australia, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2025
First Posted
July 3, 2025
Study Start
June 24, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2029
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share