Post-stroke Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 40–75 years; 2) Insomnia patients who meet the diagnostic criteria for ischemic stroke and chronic insomnia (referred to as "bù mèi" in traditional Chinese medicine, with the TCM syndrome pattern of heart-spleen deficiency type), and non-insomnia patients who only meet the diagnostic criteria for ischemic stroke. All patients are in the recovery phase, specifically 14 days to 6 months after stroke onset; 3) First-ever stroke, with no insomnia symptoms prior to the ischemic stroke; 4) MoCA > 26 points, SAS < 50 points, SDS < 53 points; 5) Muscle strength on the affected side graded 3–4, with Brunnstrom stage IV–V; 6) No use of sedative-hypnotic medications, or having discontinued such medications for at least 2 weeks; 7) Clear consciousness, no significant intellectual impairment, adequate verbal expression ability, and capable of independently completing questionnaires and various assessment evaluations; 8) Willing to participate voluntarily in the investigation and evaluation of this study, and having signed informed consent forms prior to the investigation; 9) Not participating in other clinical studies.
Exclusion criteria
Exclusion criteria: 1.Individuals unable to express themselves due to severe disturbances of consciousness, dementia, aphasia, deafness, or agnosia. 2.Patients with sleep disorders related to respiration, circadian rhythm sleep disorders, or parasomnias. 3.Patients with insomnia caused by systemic diseases such as pain, fever, or cough. 4.Patients with severe primary diseases involving the cardiovascular, pulmonary, hepatic, renal, or hematopoietic systems. 5.Patients with psychiatric disorders. 6.Patients with progressive malignant tumors or other severe consumptive diseases that are prone to co-infection and bleeding. 7.Those who do not meet the inclusion criteria, have poor compliance, or fail to receive treatment as prescribed. 8.Individuals unwilling to accept this clinical trial protocol. 9.Patients with insomnia caused by substance abuse or medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnography;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue level;Activities of Daily Living;Traditional Chinese Medicine (TCM) Syndrome Score for Insomnia of the Heart-Spleen Deficiency TypeTraditional Chinese Medicine (TCM) Syndrome Score Scale; | — |
Countries
China
Contacts
Changchun University of Chinese Medicine