Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093347
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-09-25
Brief Title:
Central Apnoea Monitor Study
Sponsor:
Sheffield Childrens NHS Foundation Trust
Organization:
Sheffield Childrens NHS Foundation Trust
Study Overview
Official Title:
Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Childrens Hospital The central apnoea monitor will be placed around the childs abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None