Memory Training in Insomnia With Cognitive Impairment

NCT06969066 | Recruiting

• 1 other identifier: CI-CRT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Therapy/Methods; Insomnia Chronic; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.

  The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

  Baseline, 6 weeks

Secondary Outcomes (12)

• The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.

  Baseline, 3 months, 6 months, 12 months

• The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

Study Arms (2)

CRT plus Sleep Hygiene Education

EXPERIMENTAL

Behavioral: Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)

Sleep Hygiene Education Only

ACTIVE COMPARATOR

Behavioral: Sleep Hygiene Education Only (SHE)

Interventions

Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE) BEHAVIORAL

Participants will receive Cognitive Remediation Therapy (CRT) combined with Sleep Hygiene Education (SHE). CRT includes structured training sessions targeting attention, memory, visuospatial skills, calculation ability, logical reasoning, and language abilities. Sessions will be conducted daily for 50 minutes over 6 weeks. Sleep Hygiene Education will cover standard recommendations to improve sleep behaviors.

CRT plus Sleep Hygiene Education

Sleep Hygiene Education Only (SHE) BEHAVIORAL

Participants will receive Sleep Hygiene Education (SHE) only, including guidance on adjusting sleep schedules, maintaining healthy sleep environments, minimizing stimulant intake, and managing sleep-related behaviors, without any CRT intervention.

Sleep Hygiene Education Only

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Central Study Contacts

Hongxing Wang, MD &amp; PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)