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:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT05703061
Eligibility Criteria:
Inclusion Criteria:
* Parent-reported child age of 14-17 years
* Typical sleep duration of approximately 7hr/night on school nights
* BMI for age and gender in the \>5th percentile but not greater than 100% overweight.
* Parent must be the primary caretaker and at home during bed/wake times
* Reported willingness and ability to complete all study-related tasks, including wearing the wrist actigraph and hip accelerometer daily.
Exclusion Criteria:
* Diagnosable sleep disorder (including Sleep Disordered Breathing) based on parent report and participant's score on Sleep Disorders Inventory for Students-Adolescents (SDIS-A).
* Medication use or parent-reported diagnosis of a serious medical condition (including psychiatric conditions) that may impact sleep.
* Excessive intake of caffeine (\>300mg/day), drug (including nicotine) or alcohol use, or a history of substance abuse.
* Actively trying to lose weight.
* Trans-meridian (east-west/west-east) travel during past month or planned travel during study time frame.
* Inability to understand or complete protocol to ensure that consent/assent and reliable and valid measures are obtained.
* Sibling of enrolled subjects, to minimize risk of bias in study findings.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT05703061
Study Brief:
Protocol Section:
NCT05703061