Status:
RECRUITING
Memory Training in Insomnia With Cognitive Impairment
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Cognitive Therapy/Methods
Insomnia Chronic
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.
Detailed Description
Chronic insomnia (CI) is a prevalent sleep disorder that not only causes night-time sleep difficulties but also impairs daytime functioning and cognitive abilities, including deficits in attention, me...
Eligibility Criteria
Inclusion
- Meets the diagnostic criteria for Insomnia Disorder according to DSM-5.
- Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
- Age ≥ 8 years.
- Voluntary participation with signed informed consent.
- 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.
- Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.
Exclusion
- Presence of severe physical illnesses or major psychiatric disorders, or assessed risk of suicide.
- Diagnosed or suspected sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or currently engaged in shift work.
- Pregnancy or breastfeeding.
- Currently undergoing any form of psychological therapy.
- History of infectious diseases such as syphilis or HIV.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06969066
Start Date
November 1 2024
End Date
November 1 2025
Last Update
May 28 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053