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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04378933
Eligibility Criteria:
Inclusion Criteria
* Regular school attendance in the setting of a fixed start time.
* Adherence to ICSD-3 DSWPD diagnostic criteria.
* Average spontaneous weekend wake time ≥1 hour than school day wake time.
* Initiation of school-night sleep at 12 a.m. or later, ≥50% of the time, during a 14-day period (items 3-4 to be determined by sleep logs and actigraphy). As there are no discrete clock times associated with the ICSD-3 DSWPD description, this cutoff is based on data obtained from the 2006 Sleep in America Poll and experiences gleaned from prior recruitment.
Exclusion Criteria
* A positive urine drug abuse screen will disqualify the individual from further participation.
* Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.
* Alcohol and nicotine use will also be screened to qualify for the study. We will also screen for alcohol immediately before each DLMO assessment because alcohol acutely suppresses melatonin.
* Patients receiving medications that might contribute to sleep disturbances and/or affect treatment responses will be considered ineligible (e.g., hypnotics, antidepressants, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs), beta blockers).
* All subjects will be asked to refrain from caffeine use on the days of phase assessments, and to cease ingestion at least 6 hours prior to nightly bedtime.
* The Ishihara Color Blindness Test will be done and patients who are color blind/deficient will be disqualified from participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT04378933
Study Brief:
Protocol Section:
NCT04378933