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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT03263156
Eligibility Criteria:
Inclusion Criteria:
* Aged 6-12 years old;
* With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
* With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).
Exclusion Criteria:
* Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ\<70);
* Children with a neurological and/or medical condition that may lead to disordered sleep;
* Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;
* Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT03263156
Study Brief:
Protocol Section:
NCT03263156