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 @ 11:06 PM
Ignite Modification Date:
2025-12-24 @ 11:06 PM
NCT ID:
NCT07209969
Eligibility Criteria:
Inclusion Criteria: Adolescents aged 11-18 years old meeting the following inclusion criteria were invited to take part in the present study:
1. Having a clinical diagnosis of ADHD made by health care professionals (psychiatrist, clinical psychologist, or educational psychologist) based on self-report;
2. a DSM-5 diagnosis of insomnia disorder, and a score on ISI ≥ 9 (suggested cut-off for adolescents) (Chung et al., 2011);
3. Those who agreed to keep the same dosage of medication throughout the study up till completion of follow up assessments.
Exclusion Criteria: Adolescents were excluded if they met any of the following criteria:
1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorders, organic mental disorders, or intellectual disabilities;
2. Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. severe eczema, gastro-oesophageal reflux disease);
3. Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, based on self-reported medical history;
4. On an optimal dosage of psychostimulant or nonstimulant ADHD medications for less than a month;
5. Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids), except for the use of psychostimulant medication for ADHD;
6. Receiving ongoing pharmacological and psychological treatment for insomnia;
7. With hearing or speech deficit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07209969
Study Brief:
Protocol Section:
NCT07209969