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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02755051
Eligibility Criteria:
Inclusion Criteria:
* previous Diagnostic and Statistical Manual of Mental Disorders diagnosis of Autism Spectrum Disorder, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).
* Who have IQ\>75.
* Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night \>30 minutes that is confirmed by baseline sleep diaries.
* Participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level.
Exclusion Criteria:
* unable to provide informed consent
* unable to implement treatment due to sleep disorder other than insomnia (i.e., sleep apnea \[apnea/hypopnea index, AHI \>15\], Periodic Limb Movement Disorder (PLMD \[myoclonus arousals per hour \>15\])
* bipolar or seizure disorder (due to risk of sleep restriction treatment)
* other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02755051
Study Brief:
Protocol Section:
NCT02755051