Post-stroke sleep disturbance
Conditions
Interventions
Bian-stone plaster group:Bian-stone plaster intervention
Placebo plaster group:Placebo plaster intervention
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for cerebral infarction (ischemic stroke), with the stroke between 2 weeks and 6 months, vital signs stable, and severity assessed as mild to moderate (NIHSS = 15 points); (2) Meet the diagnostic criteria for insomnia, with insomnia onset occurring after the stroke, or pre-existing insomnia worsening after the stroke, with insomnia severity assessed as mild to moderate (7 < ISI = 21 points, 7 < PSQI = 15 points); (3) Age = 18 years; (4) Conscious, cooperative with physical examination, able to maintain a sitting position for more than 30 minutes, and capable of completing various tests; (5) No other factors affecting sleep, such as pain; (6) No skin damage, infection, or scarring at the acupoint intervention sites; (7) The study subjects and their family members have signed the informed consent form; (8) In principle, the use of sedative-hypnotic drugs and other medications that may significantly affect sleep structure and sleep quality is prohibited during the study period. If such medications were used before enrollment and at stable doses, they may be continued, but must be rigorously recorded. Concomitant medications for chronic diseases (such as antihypertensives, antidiabetics, lipid-lowering agents, etc.) may be continued if the dose has been stable for = 4 weeks, and no dose adjustments are allowed during the study period. For patients using antidepressants or anxiolytics, the dose must have been stable for = 4 weeks, and no dose adjustments or medication changes are permitted during the study period. If rescue medications are required due to the patient's condition, they must be documented in detail, and a decision shall be made regarding study discontinuation on a case-by-case basis.
Exclusion criteria
Exclusion criteria: (1) Allergy to Bian-stone plaster; (2) Presence of skin damage, infection, or scarring at the acupoint intervention sites; (3) Transient ischemic attack (TIA); (4) Presence of diseases or conditions that interfere with subjective or objective scale assessments (e.g., aphasia, severe hearing or visual impairment, etc.); (5) Patients with moderate to severe depression or anxiety disorder (HAMD = 17 points or HAMA = 14 points); (6) Any circumstances that preclude cooperation with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Sleep data detected by a sleep bracelet;Serum testing;General physical examination including body temperature, blood pressure, and heart rate; | — |
Countries
China
Contacts
Public ContactHou Zhongwei
Beijing University of Chinese Medicine
Outcome results
None listed