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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT05716906
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with ASD
* 12-18 years of age
* English speaking
* Able to understand and respond to questionnaires in English
Exclusion Criteria:
* Pregnant or breastfeeding
* Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
* Chronic medical conditions that affect sleep
* Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
* History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
* IQ \<70
* Other neurological disorder, including seizure disorder
* Diagnosed sleep disorder
* Known genetic causes of ASD
* Currently taking melatonin or those who have had an adverse reaction to melatonin in the past
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05716906
Study Brief:
Protocol Section:
NCT05716906