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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT06969066
Eligibility Criteria:
Inclusion Criteria:
1. Meets the diagnostic criteria for Insomnia Disorder according to DSM-5.
2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
3. Age ≥ 8 years.
4. Voluntary participation with signed informed consent.
5. Meets the cognitive impairment criteria associated with CI:
(1) Right-handedness. (2) Age between 55 and 75 years. (3) Education duration ≥ 12 years. (4) At least junior high school education level; fulfills Petersen's diagnostic criteria for mild cognitive impairment: 1.Subjective complaints of memory decline. 2.Duration of cognitive complaints ≥ 3 months. 3.Assessment scores: Global Deterioration Scale (GDS) rating of stage 1-2; Clinical Dementia Rating (CDR) score of 0-0.5. 4.Memory test scores falling ≥ 1.5 standard deviations below the age- and education-matched norms: MMSE ≥ 24, MoCA \< 26, Activities of Daily Living (ADL) score \> 26. 5.Memory impairment as the primary deficit, with relatively preserved functioning in other cognitive domains.
6.Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.
Exclusion Criteria:
1. Presence of severe physical illnesses or major psychiatric disorders, or assessed risk of suicide.
2. Diagnosed or suspected sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or currently engaged in shift work.
3. Pregnancy or breastfeeding.
4. Currently undergoing any form of psychological therapy.
5. History of infectious diseases such as syphilis or HIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT06969066
Study Brief:
Protocol Section:
NCT06969066