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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05270369
Eligibility Criteria:
Inclusion Criteria:
* (1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies to cover a wider developmental span in adolescence);
* (2) Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
* (3) Willing to comply with the study protocol;
* (4) Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents)
Exclusion Criteria:
* (1) A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
* (2) Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. 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, as ascertained by the Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria;
* (4) Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter (OTC) medications (e.g. melatonin, Traditional Chinese Medicine, TCM);
* (5) Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
* (6) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI);
* (7) Currently receiving any structured psychotherapy;
* (8) With hearing or speech deficit; (9) Night shift worker.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
20 Years
Study:
NCT05270369
Study Brief:
Protocol Section:
NCT05270369