College of Health Research Complex--University of Utah
Salt Lake City, Utah, 84112, United States
Location status: Recruiting
NCT Number: NCT06180837
The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 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 participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84112, United States
Location status: Recruiting
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 1:1 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 1:1 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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sleep extension-based intervention focused on increasing time spent in bed by 2 hours per night by directly scheduling assigned bed and waketimes based on participant's individual schedules. Participants will receive weekly sleep tips and counseling on improving their sleep duration.
Time frame: Immediately after the intervention
Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.
Time frame: Immediately after the intervention
Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Wrist-actigraphy
Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Time frame: During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.
Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of two weekdays and one weekend day
Time frame: Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)
Time frame: Immediately after the intervention
Targeted metabolomics assay, 32 total metabolites.
Time frame: Immediately after the intervention
dim-light melatonin onset quantified from salivary melatonin samples
Time frame: Immediately after the intervention
Nurses will collect height and body weight using standard procedures.
Time frame: Immediately after the intervention
The Cardiac Event Risk Test 1 (CERT1) is used to evaluate the risk of major adverse cardiovascular events and can be calculated using data from our targeted metabolomics assay. The scale is from 0-12, 0 being the lowest risk and 12 being the highest level of risk.
Contact information is provided by the study sponsor or research team.
University of Utah
Other
Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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