Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648109
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Effects of Sleep Body Temperature on Body Composition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Sleep Body Temperature on Body Composition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This will be a crossover controlled trial designed to recruit 40 participants who will be divided into two groups of 20 subjects each The participants will be randomly assigned to either Group A or Group B Group A will receive the sleep electric blanket intervention for a period of 7 days while Group B will serve as the control group without any additional intervention After the intervention period there will be a washout period of 7 days to ensure that any effects of the intervention have subsided before the crossover
Following the washout period the groups will switch roles Group B will then receive the sleep electric blanket intervention and Group A will become the control group This second phase will also last for 7 days preceded and followed by the same assessment procedures as the initial phase This design will allow for a comparison of the interventions effects against a control period within the same group of participants enhancing the studys internal validity
Following the washout period the groups will switch roles Group B will then receive the sleep electric blanket intervention and Group A will become the control group This second phase will also last for 7 days preceded and followed by the same assessment procedures as the initial phase This design will allow for a comparison of the interventions effects against a control period within the same group of participants enhancing the studys internal validity
Detailed Description:
None
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