Insomnia after Ischemic Stroke
Conditions
Interventions
Control group:No intervention
Sponsors
Shanghai Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female over 18 under 75 years old; 2. Meet the diagnostic criteria of ischemic stroke according to Guidelines for the diagnosis and treatment of acute ischemic stroke in 2014 in China between 2 weeks and 2 years; 3. Meet the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition at least 1 month; 4. Score of 6 or above on the PSQI; 5. Score of 8 or above on the ISI; 6. Demonstrates no problems with communication, both visual and auditory (reading, writing, hearing, speaking, and watching); 7. Signed the written informed consent form for the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Insomnia occurs before the stroke; 2. Had a history of sleep apnea syndrome; 3. Had a history of severe neural or psychiatric disorder or major neuropsychiatric disorder (for example, autism, learning disorder, mental retardation, and so on); 4. Had severe primary diseases of the cardiovascular system, liver, kidney, or hematopoietic system; 5. Had infection or inflammation at the acupoints; 6. Had a hemorrhagic disease or anticoagulant intake; 7. Had taken Western and/or Oriental medicine in the past 2 weeks for insomniadepression or anxiety; 8. Has received acupuncture for insomnia treatment in the past month; 9. Has participated in any other clinical trial in the last 3 months; 10. Pregnancy, breast-feeding, or being a woman of childbearing age not on a proper method of birth control; 11. Refused to wear a wristwatch-like actigraphy when sleeping.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Scale (ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI);National Institutes of Health Stroke Scale (NIHSS);Stroke Specific Quality of Life Scale (SS-QOL);Zung Self-Rating Anxiety Scale (SAS);Zung Self-Rating Depression Scale (SDS);Sleep diary;dose of estazolam;Actigraphy; | — |
Countries
China
Contacts
Public ContactYan Cao
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed