Cognitive training for insomnia with cognitive impairment
Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment
This study tests if a new cognitive training program can help people with chronic insomnia and mild memory problems sleep better and improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06969066 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 to 75 with chronic insomnia and mild cognitive impairment.
Not a fit: Patients with severe cognitive impairment or those not meeting the diagnostic criteria for insomnia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cognitive function and sleep quality for patients with chronic insomnia and cognitive impairment.
How similar studies have performed: While empirical evidence for CRT in this specific population is limited, similar cognitive training approaches have shown promise in psychiatric populations.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.