Post-Stroke Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 40 and 80 years old regardless of gender. 2. Meeting the above diagnostic criteria of traditional Chinese medicine (TCM) and western medicine with insomnia secondary to stroke. 3. In the convalescent period of stroke (disease course within 6 months) conscious stable vital signs and without obvious cognitive or language disorders. 4. Pittsburgh Sleep Quality Index (PSQI) score >7 and insomnia severity classified as mild moderate or severe (Insomnia Severity Index [ISI] score: 8–28 points). 5. Not taking sedative-hypnotic drugs before admission and within 2 weeks of admission. 6. No history of mental disorders such as sleep disorders anxiety or depression before stroke. 7. The patient or legal guardian voluntarily participates signs the informed consent form and agrees to cooperate with completing relevant evaluations.
Exclusion criteria
Exclusion criteria: 1. Aged under 40 or over 80 years old. 2. Not meeting the above diagnostic criteria of traditional Chinese medicine (TCM) and western medicine. 3. History of stroke occurrence =3 times. 4. Severe post-stroke condition with severe disturbance of consciousness or inability to cooperate with treatment and scale assessment due to apraxia aphasia cognitive impairment etc. 5. Taking sedative-hypnotic drugs before admission. 6. History of sleep disorders anxiety depression or other mental disorders before stroke onset. 7. Complicated with severe heart lung or renal failure or other serious diseases that prevent cooperation with treatment and scale scoring.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Efficacy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The score of Barthel Index (BI);The score of Insomnia Severity Index (ISI);The score of Stroke Specific Quality of Life (SS-QOL) Scale;The score of National Institutes of Health Stroke Scale (NIHSS);Melatonin (MT) detection;The score of Hospital Anxiety and Depression Scale (HADS);Sleep Parameters; | — |
Countries
China
Contacts
The First Affiliated Hospital of Hunan University of Chinese Medicine