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StrokeNCT06079385

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

A study testing Acupuncture treatment in people with Stroke and Complementary, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Complementary
What is being tested?
Acupuncture treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2022to 2 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Being tested
Acupuncture treatment
Keywords
acupuncture, sleep medicine, stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture treatmentOther

    Acupuncture treatment with needles

Study groups in NCT06079385
Study groupRoleWhat they receive
Acupuncture groupExperimentalThe patients who received acupuncture treatment in addition to a standard rehabilitation program
Receives: Other: Acupuncture treatment
Control groupNo interventionThe patients who received the standard rehabilitation program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 day, 4th week and 8th week

Secondary outcomes (4)

  1. 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

    Measured: 0 day, 4th week and 8th week

  2. 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.

    Measured: 0 day, 4th week and 8th week

  3. 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

    Measured: 0 day

  4. 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

    Measured: 0 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Jul 2022
  3. Primary completion1 Oct 2022
  4. Study completion2 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079385
Sponsor's protocol ID
IstPRMTRH3
Status last verified
Feb 2024
First submitted
6 Oct 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19922248

  • 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.

    PubMed 32791749

  • 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.

    PubMed 36767777

  • 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.

    PubMed 27430619

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture treatment in people with Stroke and Complementary, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (time frame: 0 day, 4th week and 8th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079385, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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