The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients

Study Overview
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Brief Summary
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The aim of this study is to investigate the effectiveness and reliability of acupuncture treatment in patients experiencing impaired sleep quality after a stroke. Additionally, the goal is to reduce the need for multiple medications and/or high-dose drug usage in the treatment of these complications in patients

Detailed Description
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The aim of this study is to evaluate the effect of acupuncture therapy on sleep quality in patients experiencing insomnia in the early post-stroke period. In this prospective, randomized controlled, single-blind study, 70 ischemic stroke patients undergoing inpatient rehabilitation were included. Participants were randomly divided into two groups: the acupuncture group receiving acupuncture therapy and standard rehabilitation program. The control group receiving only the standard rehabilitation program. The acupuncture group received acupuncture treatment twice a week for 4 weeks. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI scores were assessed three times at baseline, at the 4th week, and at the 8th week. The results of the study indicated that the acupuncture group demonstrated a significant improvement in sleep quality compared to the control group. Significant differences were observed between the baseline PSQI scores and the PSQI scores at the 4th week in both the acupuncture and control groups (p: 0.000 and p: 0.008). The change between baseline and 8th-week PSQI scores was also significant (p: 0.000 and p: 0.000). However, in the acupuncture group, the decrease in PSQI scores was significantly greater compared to the control group. The addition of acupuncture therapy to standard treatment resulted in a significant improvement in sleep quality. Additionally, the baseline PSQI scores were found to be correlated with the severity of depression.This study suggests that acupuncture therapy can be an effective intervention for improving sleep quality in patients with early post-stroke insomnia.

Official Title
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The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients

Conditions
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Stroke, Complementary

Intervention / Treatment
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* Other: Acupuncture treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being between 18-80 years of age, having a minimum of 2 and a maximum of 6 months elapsed since the ischemic stroke, -volunteering to participate in the study, having a mini-mental test score above 17. Exclusion Criteria: history of insomnia or depression before stroke, psychiatric medication use, psychiatric illness, aphasia, sleep apnea syndrome, decompensated cardiac, renal, or hepatic insufficiency, pregnancy, presence of infection in the areas where acupuncture would be applied.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>The patients who received acupuncture treatment in addition to a standard rehabilitation program | Other: Acupuncture treatment<br>* Acupuncture treatment with needles<br>|
| No Intervention: Control group<br>The patients who received the standard rehabilitation program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | The index helps to evaluate sleep quality of patient. The scores range from 0 to 21 and the authors suggest that a score >5 be considered as a significant sleep disturbance. | 0 day, 4th week and 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | The scale is used to evaluate symptoms related to depression. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale | 0 day, 4th week and 8th week | 
| Hamilton Anxiety Rating Scale | The scale is used to evaluate symptoms related to anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | 0 day, 4th week and 8th week | 
| Barthel Index | it helps to evaluate the patient's functional status. scores of 0-20 indicate total dependency scores of 21-60 indicate severe dependency scores of 61-90 indicate moderate dependency scores of 91-99 indicate slight dependency | 0 day | 
| Mini-Mental State Examination | the test is used to evaluate patient's cognitive status. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age | 0 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, acupuncture, sleep medicine