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

Primary Purpose

Stroke, Complementary

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture treatment
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring acupuncture, sleep medicine, stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture group

Control group

Arm Description

The patients who received acupuncture treatment in addition to a standard rehabilitation program

The patients who received the standard rehabilitation program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
October 6, 2023
Last Updated
October 12, 2023
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06079385
Brief Title
The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients
Official Title
The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Complementary
Keywords
acupuncture, sleep medicine, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
The patients who received acupuncture treatment in addition to a standard rehabilitation program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients who received the standard rehabilitation program.
Intervention Type
Other
Intervention Name(s)
Acupuncture treatment
Intervention Description
Acupuncture treatment with needles
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
0 day, 4th week and 8th week
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
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
Time Frame
0 day, 4th week and 8th week
Title
Hamilton Anxiety Rating Scale
Description
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.
Time Frame
0 day, 4th week and 8th week
Title
Barthel Index
Description
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
Time Frame
0 day
Title
Mini-Mental State Examination
Description
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
Time Frame
0 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Kesiktas, MD, Prof
Organizational Affiliation
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19922248
Citation
Cao H, Pan X, Li H, Liu J. Acupuncture for treatment of insomnia: a systematic review of randomized controlled trials. J Altern Complement Med. 2009 Nov;15(11):1171-86. doi: 10.1089/acm.2009.0041.
Results Reference
background
PubMed Identifier
32791749
Citation
Xiang J, Li H, Xiong J, Hua F, Huang S, Jiang Y, Zhou X, Liao K, Xu L. Acupuncture for post-stroke insomnia: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Jul 24;99(30):e21381. doi: 10.1097/MD.0000000000021381.
Results Reference
background
PubMed Identifier
36767777
Citation
Niu S, Liu X, Wu Q, Ma J, Wu S, Zeng L, Shi Y. Sleep Quality and Cognitive Function after Stroke: The Mediating Roles of Depression and Anxiety Symptoms. Int J Environ Res Public Health. 2023 Jan 29;20(3):2410. doi: 10.3390/ijerph20032410.
Results Reference
background
PubMed Identifier
27430619
Citation
Lee SH, Lim SM. Acupuncture for insomnia after stroke: a systematic review and meta-analysis. BMC Complement Altern Med. 2016 Jul 19;16:228. doi: 10.1186/s12906-016-1220-z.
Results Reference
result

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

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