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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03730194
Eligibility Criteria:
Inclusion Criteria:
* Age 10-18 years and consistently living with parental (or legal guardian) supervision.
* Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
* Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ\>70).
* Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
* Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.
Exclusion Criteria:
* Unwillingness to stop melatonin 2 months prior to enrollment in the study.
* Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
* Adolescents who are not able to take oral medication.
* Adolescents who are visually impaired with known inability to detect light.
* Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
* Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT03730194
Study Brief:
Protocol Section:
NCT03730194