Effect of Sleep Extension on Ceramides in People With Overweight and Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep Extension Intervention.
- Who it may be relevant to
- Registry conditions: Lifestyle Factors, Overweight and Obesity, Insulin Sensitivity, Eating Habit. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk
Overview
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).
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 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).
Interventions
- Behavioral Sleep Extension Intervention
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.
Primary outcome measures
- Total Plasma Ceramides [Time frame: Immediately after the intervention]
- Insulin Sensitivity [Time frame: Immediately after the intervention]
Secondary outcome measures (8)
- Average (per week) nightly total sleep time (change from baseline) [Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) sleep satisfaction change from baseline [Time frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Average (per week) timing of food intake change from baseline [Time frame: During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.]
- Average (per week) daytime alertness change from baseline [Time frame: Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment]
- Individual C16, C18, C20, C22, C24, and C24:1 Plasma Ceramides, Dihydroceramides, Glucosylceramides, and fourteen Sphingolipids. [Time frame: Immediately after the intervention]
- Circadian Phase (change from baseline) [Time frame: Immediately after the intervention]
- Body Mass Index [Time frame: Immediately after the intervention]
- Cardiac Event Risk Test 1 (CERT 1) [Time frame: Immediately after the intervention]
Eligibility criteria
Inclusion criteria
- Age: 18-45 years old; equal numbers of men and women
- Body mass index (BMI): 27.5-34.9 kg/m2
- Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months
Exclusion criteria
- Clinically diagnosed sleep disorder or major psychiatric illness
- Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
- Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
- Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
- Cancer that has been in remission less than 5 years
- Pregnant/nursing, experiencing menopause or post-menopausal
- Shift-work: current or history of within last year
- Weight change: >10% of body weight over prior six months
- Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- Currently smoking
- Alcohol intake>14 drinks per week or >3 drinks per day
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- College of Health Research Complex--University of Utah — Salt Lake City
Identifiers
NCT: NCT06180837 · 164764