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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT07066020
Eligibility Criteria:
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for enrollment:
The participant is a child aged 8 to 12 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
A parent or primary caregiver aged 18 years or older is willing and able to participate in the study.
The child demonstrates the ability to understand and follow simple instructions necessary for study procedures.
Presence of significant parent-reported insomnia symptoms, specifically defined as having bedtime resistance, sleep-onset delay, or night awakenings that occur on five to seven nights per week, as identified using the Children's Sleep Habits Questionnaire (CSHQ).
Exclusion Criteria:
Participants will be excluded if they meet any of the following criteria:
Currently receiving, or has recently completed, pharmacological or formal behavioral treatment for sleep problems.
Presence of any medical condition that significantly limits physical activity (e.g., moderate-to-severe asthma, congenital heart disease).
Diagnosis of a complex neurological disorder (e.g., epilepsy).
Presence of other known medical or psychiatric conditions that could be the primary cause of sleep disturbance (e.g., sleep apnea, restless legs syndrome, severe anxiety).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT07066020
Study Brief:
Protocol Section:
NCT07066020