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Recruiting NCT06969066

NCT06969066 Memory Training in Insomnia With Cognitive Impairment

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Clinical Trial Summary
NCT ID NCT06969066
Status Recruiting
Phase
Sponsor Xuanwu Hospital, Beijing
Condition Cognitive Therapy/Methods
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2024-11-01
Primary Completion 2025-10-01

Trial Parameters

Condition Cognitive Therapy/Methods
Sponsor Xuanwu Hospital, Beijing
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 8 Years
Max Age N/A
Start Date 2024-11-01
Completion 2025-10-01
Interventions
Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)Sleep Hygiene Education Only (SHE)

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Brief Summary

This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.

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

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