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Recruiting NCT06540716

NCT06540716 Inspire Singapore Study

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Clinical Trial Summary
NCT ID NCT06540716
Status Recruiting
Phase
Sponsor Inspire Medical Systems, Inc.
Condition Obstructive Sleep Apnea
Study Type INTERVENTIONAL
Enrollment 44 participants
Start Date 2024-08
Primary Completion 2025-08

Trial Parameters

Condition Obstructive Sleep Apnea
Sponsor Inspire Medical Systems, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 44
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2024-08
Completion 2025-08
Interventions
Inspire System

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Brief Summary

Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.

Eligibility Criteria

Main Inclusion Criteria: * Diagnosis of moderate to severe OSA (AHI 15-65) * Failure of, or intolerance to CPAP Main Exclusion Criteria: * 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.

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