Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05460598
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2022-07-04
Brief Title:
The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study
Status:
COMPLETED
Status Verified Date:
2024-08
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 single-blinded only patients blinded study is to assess the effect of cooling beddings on itch
The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20 improvement in nocturnal itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings
The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20 improvement in nocturnal itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings
Detailed Description:
Itch is the most common skin-related symptom Stayingsleeping in a bed with a cooling properties could have a positive effect on nocturnal itch intensity sleep quality and daytime performance in consequence A mattress topper and bed linen with cooling effects that are commercially available httpswwwobachcool_gel_topper by the OBA AG Basel which is the supplier of beds and bedding items of the University Hospital Basel has been used in clinical routine This single-blinded only patients blinded study is to assess the effect of cooling beddings on itch and to better rationalize the beddings use No comparative data is available and the design is purely exploratory The primary objective of this study is to test whether or not the use of the cooling beddings during 3 days can add at least 20 improvement in nocturnal itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings
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