Sleep disturbance after stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the above-mentioned diagnostic criteria of Chinese and Western medicine for stroke and insomnia and the diagnostic criteria for syndromes; (2) No history of insomnia and use of various psychotropic drugs before stroke; (3) People who sleep less than 6 hours at night after a stroke, frequently wake up from sleep, or stay awake at night; more than 3 times a week for more than 1 month; (4) The Pittsburgh Sleep Quality Score (PSQI) exceeds 7 points; (5) During the recovery period from 15 days to 180 days after the onset of stroke; (6) Unconsciousness obstacles, no obvious intelligence, language understanding and expression obstacles, able to basically complete various scale tests independently; (7) NIHSS score = 15 points; (8) 45 years old = age = 80 years old; (9) Informed consent of patients. Those who meet the above criteria at the same time can be selected.
Exclusion criteria
Exclusion criteria: (1) Patients allergic to estazolam; (2) Insomnia caused by other diseases or living habits (alcoholism, drug dependence, etc.); or those who are dependent on tranquillizers; (3) Those with severe mental symptoms; (4) Those who have participated in clinical research of other drugs in the past month, or those who have used related psychosedatives in the past two weeks; (5) Severe heart, liver (ALT, AST exceeding 50% of the upper limit of normal), kidney (BUN exceeding 20% ??of the upper limit of normal, Cr exceeding the upper limit of normal), hematopoietic system and metabolic system and other serious diseases or other People with severe diseases in various systems; (6) Women who are breast-feeding, pregnant, or likely to become pregnant during the trial period; (7) Poor compliance after enrollment, privately combined use of drugs or treatments not permitted by the trial, serious adverse reactions during treatment, loss to follow-up or refusal to continue to participate in the trial. Those that meet one of the above will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?-aminobutyric acid;5-hydroxytryptamine;Pittsburgh Sleep Quality Index;TCM Symptom Scale;Sleep rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor necrosis factor-a;National Institutes of Health Stroke Scale;Safety Analysis;Ability index of daily living activities;Comparison of onset and maintenance time;Interleukin-6; | — |
Countries
China