Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04671342
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-12-09
Brief Title:
DreamKit Diagnostic Validation
Sponsor:
Philips Clinical Medical Affairs Global
Organization:
Philips Clinical Medical Affairs Global
Study Overview
Official Title:
Diagnostic Validation of the DreamKit Device Against Polysomnography
Status:
COMPLETED
Status Verified Date:
2023-01
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:
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography
Detailed Description:
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator polysomnography PSG Data collection will be completed within a single visit in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None