Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT03500458
Eligibility Criteria:
Inclusion Criteria:
1. High school students between the age of 14-19 years
2. have typically insufficient sleep, defined by ≤ 7 hours per night on school days
3. BMI 5th-84th percentile for age and sex
4. habitually sedentary (\< 3 hours of regular physical activity per week)
5. Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Exclusion Criteria:
1. Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
2. regular use of melatonin or other sleep aids
3. a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
4. Type 2 diabetes or prediabetes
5. IQ\<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
6. teens not enrolled in a traditional high school academic program (e.g., home school students)
7. schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
8. travel across more than two time zones in the 2 weeks prior to the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
19 Years
Study:
NCT03500458
Study Brief:
Protocol Section:
NCT03500458