Recruiting

Sleep Extension

Sponsor:

University of Utah

Code:

NCT06180837

Conditions

Lifestyle Factors

Overweight and Obesity

Insulin Sensitivity

Eating Habit

Sleep Hygiene

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Sleep Extension Intervention

Study Details

Brief summary:

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).

Conditions

Lifestyle Factors

Overweight and Obesity

Insulin Sensitivity

Eating Habit

Sleep Hygiene

Study ID

NCT06180837

Start date

Feb 12, 2024

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age: 18-45 years old; equal numbers of men and women
2. Body mass index (BMI): 27.5-34.9 kg/m2
3. Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months

Exclusion Criteria:

1. Clinically diagnosed sleep disorder or major psychiatric illness
2. Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
3. Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
4. Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
5. Cancer that has been in remission less than 5 years
6. Pregnant/nursing, experiencing menopause or post-menopausal
7. Shift-work: current or history of within last year
8. Weight change: >10% of body weight over prior six months
9. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
10. Currently smoking
11. Alcohol intake>14 drinks per week or >3 drinks per day

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Group

Provided with general health information on diet and physical activity.

experimental: Intervention Group

Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.

Interventions

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 measure

  • Total Plasma Ceramides [ Time Frame: Immediately after the intervention ]
  • Insulin Sensitivity [ Time Frame: Immediately after the intervention ]

Central Contacts and Locations

Central contacts

Locations

College of Health Research Complex--University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

More Information

Sponsor

University of Utah

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • sleep
  • insulin sensitivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.