Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
NCT ID: NCT07049744
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-06-24
2029-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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XII Medical HGNS System
Participants receiving HGNS using the XII Medical System
XII Medical HGNS System
XII Medical HGNS System
Interventions
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XII Medical HGNS System
XII Medical HGNS System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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XII Medical
INDUSTRY
Responsible Party
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Locations
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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, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Perth Head & Neck Surgery
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XII-002
Identifier Type: -
Identifier Source: org_study_id
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