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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT04163003
Eligibility Criteria:
All participants will be excluded if they live more than roughly an hour's drive from Pittsburgh, Pennsylvania (PA).
Insufficient Sleepers:
Investigators will screen, deliver universal education (UE), and offer participation to all participants:
1. ages 13 years, 0 months to 15 years, 11 months;
2. able and willing to give informed assent to participate (with informed consent from parent);
3. insufficient sleep (≤7.5 hours sleep on average weeknights); and
4. weekend-weekday sleep timing shift \>=1.5 hours.
Inclusion criteria are not applicable for parents.
Exclusion Criteria:
1. Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder will exclude potential participants;
2. unstable medical conditions;
3. use of psychotropic medications or medications known to impact sleep;
4. adolescent pregnancy;
5. clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
6. current sleep disorders except for sleep-onset insomnia;
7. extreme evening preference; and
8. Currently living \>1 hour outside of the greater Pittsburgh region.
Sufficient Sleepers:
Inclusion Criteria:
1. ages 13-15;
2. sufficient sleep (\>7.5 hours of sleep);
3. willing/able to provide informed assent/consent.
Exclusion Criteria:
1. Evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder;
2. unstable medical conditions;
3. use of psychotropic medications or medications known to impact sleep;
4. adolescent pregnancy;
5. clinical levels of psychopathology, except for youth with a sole diagnosis of gender dysphoria;
6. current sleep disorders except for sleep-onset insomnia;
7. extreme evening preference; and
8. Currently living \>1 hour outside of the greater Pittsburgh region.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
15 Years
Study:
NCT04163003
Study Brief:
Protocol Section:
NCT04163003