Status:
TERMINATED
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
Lead Sponsor:
Nyxoah S.A.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft pal...
Detailed Description
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete con...
Eligibility Criteria
Inclusion
- Man or woman between 21 and 75 years of age
- 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
- Unable or incapable of providing informed written consent
- Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03763682
Start Date
January 10 2019
End Date
June 18 2024
Last Update
June 6 2025
Active Locations (4)
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1
Westmead Private Hospital
Westmead, New South Wales, Australia, 2145
2
Wollongong Private Hospital
Wollongong, New South Wales, Australia, 2500
3
Institute Breathing and Sleep Austin Hospital
Heidelberg, Victoria, Australia, 3084
4
Hollywood Hospital
Nedlands, Western Australia, Australia, 6005