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Research on Cognitive Disorders Related to Sleep Disorders

A cohort study on cognitive impairment associated with sleep disorders and its combined physical and intellectual training intervention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081739
Enrollment
Unknown
Registered
2024-03-11
Start date
2023-12-29
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

sleep disorder

Interventions

Intervention group:combined physical and intellectual rehabilitation training
Control:None

Sponsors

The Second Affiliated Hospital of South China University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for observational cohort 1) 45 = age = 59 years old; 2) Clearly diagnose sleep disorders according to the International Classification of Sleep Disorders (ICSD-3); 3) Ability to cooperate in completing neuropsychological assessments; 4) Be able to understand the purpose and procedures of this study and sign a written informed consent form. Inclusion criteria for intervention cohorts If the criteria for inclusion in the observational cohort are met, it is still necessary to meet the following requirements: 1) According to the International Classification of Sleep Disorders (ICSD-3), the type of sleep disorder is defined as insomnia; 2) A history of chronic insomnia for at least 3 months, with sleep duration 5 points or in line with the "2018 China Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Disorders (5): Diagnostic criteria for MCI in "Diagnosis and Treatment of Mild Cognitive Disorders"; 5) Not accompanied by other types of sleep disorders: such as respiratory related sleep disorders, sleep awake circadian rhythm disorders, etc.

Exclusion criteria

Exclusion criteria: 1) Serious systemic medical diseases of cardiovascular, endocrine, renal, or liver systems; 2) The state of acute exacerbation or attack of a chronic disease; 3) Acute infectious diseases; 4) Diseases related to potential cognitive impairment, including focal brain damage, traumatic brain injury with loss of consciousness or mental disorder, as well as cognitive impairment caused by nervous system diseases related to neurosyphilis, HIV central nervous system infection, Parkinson's disease, or Lewy body disease, and cognitive impairment caused by systemic diseases such as B-vitamin deficiency and hypothyroidism; 5) Mental disorders, including depression (Hamilton Depression Scale HAMD>35), anxiety (Hamilton Anxiety Scale HAMA>29), alcohol or drug abuse; 6) Neuroradiologic evaluation of conventional MR imaging revealed more than one lacunar lesion, or patchy, diffuse leukoaraiosis; 7) Clearly diagnose patients with malignant tumors; 8) Incomplete information or refusal to participate in the investigation or inability to cooperate with the test; 9) Patients who are participating in other clinical trials but have not reached the main study endpoint.

Design outcomes

Primary

MeasureTime frame
Incidence of cognitive impairment;The incidence of dementia;Assessment of daily life activity ability;parameters of polysomnography;

Secondary

MeasureTime frame
The occurrence of stroke;Sleep quality indicators;Health economics indicators;Laboratory inspection indicators;

Countries

China

Contacts

Public ContactMei Yuan

The Second Affiliated Hospital of South China University

meimeihaijun@163.com+86 186 8457 1188

Outcome results

None listed

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