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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT06627205
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with autism spectrum disorder (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised, Childhood Autism Rating Scale-2)
* with sleep disturbances (based on clinical interview, and Sleep Disturbance Scale for Children score \> 38)
* stable pre-existing medication plans for at least 2 weeks
* no planned changes in psychosocial and biomedical interventions during the intervention
* an English-speaking parent able to consistently participate in study procedures
* reside in California, USA
Exclusion Criteria:
* parent or child diagnosed with severe psychiatric disorder or unstable medical problem
* children with active seizures or epilepsy
* primary sleep disorder is a circadian rhythm sleep-wake disorder, as determined by the sleep interview and Children's ChronoType Questionnaire.
* current active trial of sleep restriction therapy or history of an adequate trial of sleep restriction therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT06627205
Study Brief:
Protocol Section:
NCT06627205