Status:
RECRUITING
Inspire Singapore Study
Lead Sponsor:
Inspire Medical Systems, Inc.
Conditions:
Obstructive Sleep Apnea
OSA
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.
Detailed Description
Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm ins...
Eligibility Criteria
Inclusion
- Main
- Diagnosis of moderate to severe OSA (AHI 15-65)
- Failure of, or intolerance to CPAP
- Main
Exclusion
- Central + mixed apneas \> 25% of total AHI
- Presence of complete concentric collapse (CCC)
- Compromised neurological control of the upper airway.
- Other eligibility criteria may apply.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06540716
Start Date
August 1 2024
End Date
December 1 2025
Last Update
August 19 2024
Active Locations (2)
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1
National University Hospital
Singapore, Singapore
2
Singapore General Hospital
Singapore, Singapore