Memory Training in Insomnia With Cognitive Impairment

Capital Medical University

Status: Enrolling

Conditions: Cognitive Dysfunction; Cognitive Therapy/Methods; Insomnia Chronic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06969066

CI-CRT

Details and patient eligibility

About

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

Full 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, memory, and executive function. Persistent insomnia may diminish the brain's information processing capacity, affecting memory, attention, and decision-making. CRT, a structured cognitive training intervention, has been shown in psychiatric populations to enhance memory, attention, and executive function by promoting neuroplasticity, neurotransmitter modulation, and optimizing brain activity patterns.

Applying CRT to CI patients may similarly support cognitive recovery and indirectly improve sleep quality. However, empirical evidence remains limited.

This randomized controlled trial will enroll 70 patients with CI and cognitive decline. Participants will be randomly assigned to either a CRT plus Sleep Hygiene Education (SHE) group or an SHE-only group (n=35 each). The CRT intervention will last 6 weeks, with daily 50-minute sessions. Evaluations will occur at baseline, post-intervention, and at 3, 6, and 12 months follow-up. This study aims to provide evidence for CRT as a treatment for CI with cognitive impairment and inform future clinical practices.

Enrollment: 70 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

CRT plus Sleep Hygiene Education

Experimental group

Treatment:

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

Sleep Hygiene Education Only

Active Comparator group

Treatment:

Behavioral: Sleep Hygiene Education Only (SHE)