Cognitive training for insomnia with cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on patients suffering from chronic insomnia and mild cognitive impairment. The study will enroll 70 participants who will be randomly assigned to either a group receiving CRT combined with Sleep Hygiene Education or a group receiving only Sleep Hygiene Education. The CRT intervention consists of daily 50-minute sessions over six weeks, aiming to enhance cognitive functions such as memory and attention, which may also improve sleep quality. Evaluations will be conducted at multiple time points to assess the effectiveness of the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Hongxing Wang, MD & PhD
• Email: wanghongxing@xwh.ccmu.edu.cn
• Phone: +86 13911127385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.