NCT07618117 Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
| NCT ID | NCT07618117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Overweight Adolescents |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-10-20 |
| Primary Completion | 2030-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-10-20 with a primary completion date of 2030-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Stacey L Simon
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT07618117 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 19 Years, studying Overweight Adolescents. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07618117 currently recruiting?
Yes, NCT07618117 is actively recruiting participants. Contact the research team at stacey.simon@childrenscolorado.org for enrollment information.
Where is the NCT07618117 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07618117 clinical trial?
NCT07618117 is sponsored by University of Colorado, Denver. The principal investigator is Stacey L Simon at University of Colorado, Denver. The trial plans to enroll 60 participants.