Clinical trial NCT06079385: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Complementary
Keywords: acupuncture
sleep medicine
stroke
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 0 day, 4th week and 8th week
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 0 day, 4th week and 8th week
measure: Hamilton Anxiety Rating Scale
timeFrame: 0 day, 4th week and 8th week
measure: Barthel Index
timeFrame: 0 day
measure: Mini-Mental State Examination
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
name: Nur Kesiktas, MD, Prof
role: STUDY_CHAIR
References:
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.
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.
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.
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.