Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents (REST)

University of Colorado Denver (CU Denver)

Status: Begins enrollment in 1 month

Conditions: Overweight Adolescents; Insulin Sensitivity; Sleep

Treatments: Behavioral: Circadian/Sleep (C/S)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07618117

25-1531

1R01DK142774-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Typical Sleep

No Intervention group

Description:

Habitual sleep schedule

Circadian/Sleep (C/S) Condition

Experimental group

Description:

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

Treatment:

Behavioral: Circadian/Sleep (C/S)