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Brain network analysis, clinical course prediction, and intervention research in mild cognitive impairment coexisting with sleep disturbance

Brain network analysis, clinical course prediction, and intervention research in mild cognitive impairment coexisting with sleep disturbance

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068698
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment?sleep disturbance

Interventions

Study II (1 group):Transcranial magnetic stimulation-Alternating current stimulation
Study II (2 group):Cognitive behavioral therapy for insomnia combined with cognitive training for mild cognitive impairment
Study II (3 group):Sham stimulation
Study I (MCI patients with insomnia complaints):N/A
Study 1 (MCI patients without complaints of sleep disorder):N/A

Sponsors

Department of Psychology and Behavioral Sciences, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: Study 1 1. Meeting the MCI diagnostic criteria advocated by Peterson's team and other teams or chief complaint of cognitive decline; 2. Age >=55 and = 28, MoCA>= 26; 3.CDR score is 0; 4. There is no chief complaint of sleep disorder, and it does not meet any diagnostic criteria of sleep disorder in ICSD-3; 5. The subject is a native speaker of Chinese, can see and hear normally and can cooperate to complete all test items; 6. At least 6 years of education;

Exclusion criteria

Exclusion criteria: Study 1 1. Patients with severe mental illness or congenital mental retardation 2. Other medical conditions or medical history that affect cognitive function 3. Patients with severe heart, liver, lung and kidney diseases and other serious systemic diseases 4. Patients with severe infectious diseases and patients with toxic encephalopathy 5. A history of alcohol or drug abuse Study 2 1.PSG monitoring suggested the presence of REM atonia and dream deduction behavior 2. Taking drugs to improve memory or treat AD within the last 3 months 3. Taking sedative hypnotic drugs and anti-anxiety and depression drugs unsteadily in the past month; 4. Patients with metal implants such as cardiac pacemakers, coronary stents and aneurysm clips Study 3 High-risk conversion patients with MCI and insomnia: 1. There are other sleep disorders that meet the diagnostic criteria of ICSD-3; 2. Neuropsychological disease; 3. Clinically diagnose other neurological diseases (such as Parkinson's disease); 4. Acute DM complications or acute cerebrovascular diseases; 5. Patients with a history of alcoholism or drug addiction, or neurological diseases that can cause cognitive impairment such as brain trauma, epilepsy, encephalitis, normal cranial pressure hydrocephalus; 6. Systemic diseases that may lead to mild cognitive impairment (e.g., liver and kidney insufficiency, endocrine disorders, vitamin deficiency); 7. Those who do not have independent behavior ability and/or have communication barriers; 8. Participating in clinical research of other drugs; 9. Participants in this study were not considered appropriate for other reasons. Patients with MCI without insomnia 1.PSQI score > 5; 2. Neuropsychological disease; 3. Clinically diagnose other neurological diseases (such as Parkinson's disease); 4. Acute DM complications or acute cerebrovascular diseases; 5. Patients with a history of alcoholism or drug addiction, or neurological diseases that can cause cognitive impairment such as brain trauma, epilepsy, encephalitis, normal cranial pressure hydrocephalus; 6. Systemic diseases that may lead to mild cognitive impairment (e.g., liver and kidney insufficiency, endocrine disorders, vitamin deficiency); 7. Those who do not have independent behavior ability and/or have communication barriers; 8. Participating in clinical research of other drugs; 9. Participants in this study were not considered appropriate for other reasons. Healthy control 1. Meet the MCI criteria and the standard definition of dementia based on DSM-5; 2. In the last 3 months, have taken drugs that affect the central nervous system; 3. Neuropsychological disease; 4. Clinically diagnose other neurological diseases (such as Parkinson's disease); 5. Acute DM complications or acute cerebrovascular diseases; 6. Patients with a history of alcoholism or drug addiction, or neurological diseases that can cause cognitive impairment such as brain trauma, epilepsy, encephalitis, normal cranial pressure hydrocephalus; 7. Systemic diseases that may lead to mild cognitive impairment (e.g., liver and kidney insufficiency, endocrine disorders, vitamin deficiency); 8. Those who do not have independent behavior ability and/or have communication difficulties; 9. Participating in clinical research of other drugs; 10. Participants in this study were deemed unsuitable for other reasons.

Design outcomes

Primary

MeasureTime frame
Magnetic resonance data (T1, T2);Electroencephalogram data (EEG);Magnetic resonance data (fMRI);Diffusion tensor Imaging (DTI);SNP sequencing;DNA methylation;vitamin B12;Thyroid function indicators;Inflammatory cytokines (IL-1ß, IL-6, TNF-a);Neurodegenerative markers proteins;

Countries

China

Contacts

Public ContactChen, Ji

Department of Psychology and Behavioral Sciences, Zhejiang University

ji.chen@zju.edu.cn13738103217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026