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Complementary medicine
Protocol
Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial
  1. Cong Wang1,
  2. Wen-jia Yang1,
  3. Xin-tong Yu2,
  4. Cong Fu1,
  5. Jin-jin Li1,
  6. Jing Wang1,
  7. Wen-lin Xu1,
  8. Yi-xin Zheng1,
  9. Xin-yu Chen3,
  10. Yun-fei Chen1
  1. 1Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  2. 2Laboratory Center of Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  3. 3Beijing University of Chinese Medicine Dongfang College, Beijing, China
  1. Correspondence to Professor Yun-fei Chen; icyf1968{at}163.com

Abstract

Introduction Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.

Methods and analysis This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.

Ethics and dissemination This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.

Trial registration number ChiCTR1900023473; Pre-results.

  • acupuncture
  • insomnia
  • short sleep duration
  • protocol
  • randomised controlled trial
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-033731

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    Footnotes

    • Correction notice The article has been corrected since it is published. The authorship has been updated and Xin-yu Chen has been added as an author in the author list.

    • Contributors CW and Y-fC conceived the research plan. CW and W-jY drafted the protocol. X-tY, CF, J-jL and JW coordinated the study. W-lX, Y-xZ and CW recruited the subjects. CW and W-jY formed the analysis plan. X-yC assisted the subject in completing the questionnaire.

      All authors participated in, read and approved the final manuscript.

    • Funding This work was supported by: The Construction of Chinese Medicine Heritage Innovation Platform (Project No.: ZY (2018-2020)-CCCX-2004-03); The Shanghai Science and Technology Commission (Project No.: 18401971000); The Shanghai Municipal Commission of Health and Family Planning (Project No.: ZYKC201703006); The National Natural Science Foundation of China (Grant No. 81503631); The Interdisciplinary Project of “Clinical Immunology of Traditional Chinese Medicine” in Shanghai (Project No.: 30304113598); The National Natural Science Foundation of China (Grant No. 81904300); The National Natural Science Foundation of China (Grant No. 81804200).

    • Disclaimer This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The trial has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (No.: 2019-17).

    • Provenance and peer review Not commissioned; externally peer reviewed.

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