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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT03155750
Eligibility Criteria:
Inclusion Criteria:
* Adults age 18-65 years old;
* Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
* A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months;
* Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
* Willing to give informed consent and comply with the trial protocol;
* Ambulant and independent in activities of daily living;
* Physically inactive which refers to less than 150 minutes moderate-intensity activity per week or less than 75 minutes vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous- intensity activity.
Exclusion Criteria:
* Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;
* Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
* Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
* cognitive impairment preventing informed consent or understanding of instructions (score \< 22 in Montreal Cognitive Assessment Hong Kong version);
* Shift work;
* body mass index equal to or over 27.5, the obese criteria for Asians;
* Unsafe conditions or incapable to exercise as recommended by their physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03155750
Study Brief:
Protocol Section:
NCT03155750