NCT06079385

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

October 6, 2023

Last Update Submit

February 18, 2024

Conditions

StrokeComplementary

Keywords

acupuncturesleep medicinestroke

Outcome Measures

Primary Outcomes (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.

    0 day, 4th week and 8th week

Secondary Outcomes (4)

  • Hamilton Depression Rating Scale

    0 day, 4th week and 8th week

  • Hamilton Anxiety Rating Scale

    0 day, 4th week and 8th week

  • Barthel Index

    0 day

  • Mini-Mental State Examination

    0 day

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Other: Acupuncture treatment

Control group

NO INTERVENTION

The patients who received the standard rehabilitation program.

Interventions

Acupuncture treatmentOTHER

Acupuncture treatment with needles

Acupuncture group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 19922248BACKGROUND

  • 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.

    PMID: 32791749BACKGROUND

  • 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.

    PMID: 36767777BACKGROUND

  • 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.

    PMID: 27430619RESULT

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Nur Kesiktas, MD, Prof

    İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

July 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 2, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)