Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180837
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-11-14
Brief Title:
Effect of Sleep Extension on Ceramides in People With Overweight and Obesity
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The overall goal is to determine how a sleep extension intervention increasing time in bed in individuals who maintain less than 65 hours sleep per night affects their plasma ceramides and insulin sensitivity Participants will undergo a randomized controlled trial with sleep extension intervention and healthy lifestyle control groups The sleep extension is designed to increase participants time in bed by 2 hours per night Alternatively the control group will receive basic health information eg physical activity goal setting and nutrition when eating out
Detailed Description:
A randomized controlled trial with real-world sleep extension in adults with overweight and obesity who habitually obtain short sleep duration will be conducted Group allocation will be 11 and research staff and participants will be blinded until the conclusion of the baseline segment The sleep extension group will receive counseling and instruction to increase nightly time in bed by 2 hours per night Participants randomized to control will maintain their habitual sleep habits in their home environment The intervention segment will last 8 weeks regardless of group assignment Both groups will have equal contact time with the study team
Prior to enrollment participants will complete a clinical overnight sleep disorders screening Baseline consists of an 1-week ambulatory real-world monitoring segment Following baseline participants will be randomized 11 to either the sleep extension or control group for 8 weeks at home intervention segment Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides targeted metabolomics assay and insulin sensitivity hyperinsulinemic-euglycemic clamp
Prior to enrollment participants will complete a clinical overnight sleep disorders screening Baseline consists of an 1-week ambulatory real-world monitoring segment Following baseline participants will be randomized 11 to either the sleep extension or control group for 8 weeks at home intervention segment Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides targeted metabolomics assay and insulin sensitivity hyperinsulinemic-euglycemic clamp
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