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 @ 11:49 AM
Ignite Modification Date:
2025-12-24 @ 11:49 AM
NCT ID:
NCT05402761
Eligibility Criteria:
Inclusion Criteria:
* have received a diagnosis of TBI at least 3 months before enrollment (TBI in chronic stage),
* yield an initial (i.e., rated in the emergency room) GCS score of 3-15 (mild to severe) and have GCS score of 15 when enrolling into the study,
* report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months,
* have post-TBI insomnia with a total score \> 7 on the Chinese version of the insomnia severity scale (CISI) at screening,
* be able to communicate in Mandarin Chinese, and be able to complete cognitive tasks (having Rancho Los Amigos Levels of Cognitive Functioning scale score \> 9)
Exclusion Criteria:
* include premorbid diagnoses of seizure,
* sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score \> 3),
* psychiatric diseases,
* substance abuse,
* alcoholism
* Shift workers and women who are pregnant, breastfeeding, or in the menopausal transition
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT05402761
Study Brief:
Protocol Section:
NCT05402761