BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
NCT ID: NCT03763682
Last Updated: 2025-06-06
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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TERMINATED
NA
42 participants
INTERVENTIONAL
2019-01-10
2024-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Genio(TM) system therapy
Genio(TM) bilateral hypoglossal nerve stimulation system
Genio(TM) bilateral hypoglossal nerve stimulation system
Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation
Interventions
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Genio(TM) bilateral hypoglossal nerve stimulation system
Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤ 32 kg/m2
* Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
* Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.
Exclusion Criteria
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
21 Years
75 Years
ALL
Yes
Sponsors
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Nyxoah S.A.
INDUSTRY
Responsible Party
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Locations
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Westmead Private Hospital
Westmead, New South Wales, Australia
Wollongong Private Hospital
Wollongong, New South Wales, Australia
Institute Breathing and Sleep Austin Hospital
Heidelberg, Victoria, Australia
Hollywood Hospital
Nedlands, Western Australia, Australia
Countries
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Other Identifiers
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BETTER SLEEP
Identifier Type: -
Identifier Source: org_study_id
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