Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540716
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Inspire Singapore Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Inspire Singapore Study Confirmation of Therapy Performance
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inspiratory overlap 1st PSG after therapy activation titrate the therapy 2nd PSG at 3 months post-activation and confirm therapy performance 3rd PSG at 6 months post-activation Symptoms and quality of life assessed by ESS and FOSQ therapy adherence and adverse events will also be collected and reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None