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:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT04890002
Eligibility Criteria:
Inclusion Criteria:
* Chinese Hong Kong residents who are able to read Chinese;
* Aged 18 - 65 years;
* Subjective sleep complaints of having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with consequences for daily life for at least 3 months.
* Pittsburgh Sleep Quality Index total score of at least 5 indicating sleep disturbance with 89.6% sensitivity and 86.5% specificity; and
* Willing to give informed consent and comply with the trial protocol.
Exclusion Criteria:
* Currently receiving psychotherapy or participating in other clinical trials for insomnia;
* Pregnancy;
* Shift workers;
* At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
* No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
* Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04890002
Study Brief:
Protocol Section:
NCT04890002