Recruiting

Sleep Intervention

Sponsor:

University of Colorado, Denver

Code:

NCT07618117

Conditions

Overweight Adolescents

Sleep

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Interventions

Circadian/Sleep (C/S)

Study Details

Brief summary:

Many teenagers get too little and late timed sleep. High body weight and diabetes are increasing in teenagers as well. This study plans to learn more about whether improving sleep habits can help improve how the body regulates blood sugar and energy use in teenagers who have higher body weight. To answer this question, the investigators plan to enroll teenagers who get <7 hours of sleep on school nights and measure changes in blood sugars and energy use after two weeks of typical sleep (sleeping on their normal school schedule) and two weeks of a sleep intervention that includes spending longer time in bed at night, melatonin, and morning light.

Conditions

Overweight Adolescents

Sleep

Insulin Sensitivity

Study ID

NCT07618117

Start date

Oct 20, 2026

Status verified date

Nov, 2026

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Jun 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. High school students between 14-19 years
2. Overweight/obesity (BMI >85% for age and sex)
3. Have habitually insufficient sleep, defined as ≤ 7 hours per night on school days
4. Habitually inactive (≤ 3 h of physical activity reported per week)
5. Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

Exclusion Criteria:

1. Reported diagnosis of sleep disorder (e.g., insomnia, obstructive sleep apnea)
2. Medical comorbidities that impact sleep or insulin sensitivity (e.g., diabetes \[based on history or screening HbA1c\])
3. Regular use of medications affecting sleep or insulin sensitivity (e.g., stimulants, sleep aids, systemic steroids, insulin sensitizers, GLP-1 agonists)
4. IQ<70 or severe mental illness that may impact sleep or study participation (e.g., schizophrenia), eating disorder, or active suicidal ideation
5. Schedules that would preclude participants from adhering to the sleep schedules (e.g., night-shift employment)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Typical Sleep

Habitual sleep schedule

experimental: Circadian/Sleep (C/S) Condition

1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking

Interventions

Circadian/Sleep (C/S)

1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking

Primary outcome measure

  • Insulin sensitivity [ Time Frame: Assessed at 2 weeks following each condition ]

Central Contacts and Locations

Central contacts

Stacey L Simon, PhD

720-777-5681stacey.simon@childrenscolorado.org

Angel Arias, BS

720-777-3491angel.arias@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Angel Arias, BS

720-682-8925RESTStudy@childrenscolorado.org

Principal Investigator:

Stacey Simon, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.