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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT06004869
Eligibility Criteria:
Inclusion Criteria:
1. Hong Kong residents at least 18 years of age;
2. able to read Chinese and type in Chinese or English;
3. meet the DSM-5 diagnostic criteria of insomnia disorder (difficulty initiating and/or maintaining sleep or early morning awakening, alongside clinically significant daytime impairment) based on the Brief Insomnia Questionnaire (BIQ), a diagnostic tool validated by the team;
4. have an Insomnia Severity Index (ISI) score of at least 10 indicating clinical-level insomnia;
5. have adequate opportunity and circumstances for sleep to occur;
6. have an Internet-enabled mobile device (iOS or Android operating system), and
7. are willing to provide informed consent.
Exclusion Criteria:
To mimic real-world settings, a less stringent set of exclusion criteria will be adopted.
1. A Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk);
2. involvement in CBT-I in the past 6 months;
3. a history of severe mental illness (e.g., bipolar disorder, psychotic disorder);
4. major medical or neurocognitive disorders or side effects of medication that contribute significantly to insomnia or make participation infeasible based on the team's clinical experience;
5. other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores (≥7 on narcolepsy; ≥15 on OSA; ≥7 on RLS/PLMD) in SLEEP-50;
6. taking over-the-counter medication or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment; and
7. shift work, pregnancy, family or other commitments that interfere with regular sleep-wake patterns.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06004869
Study Brief:
Protocol Section:
NCT06004869