Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial
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...
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BMJ Publishing Group
2020-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/3/e033731.full |
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| author | Jing Wang Cong Wang Wen-jia Yang Xin-tong Yu Cong Fu Jin-jin Li Wen-lin Xu Yi-xin Zheng Yun-fei Chen Xin-yu Chen |
| author_facet | Jing Wang Cong Wang Wen-jia Yang Xin-tong Yu Cong Fu Jin-jin Li Wen-lin Xu Yi-xin Zheng Yun-fei Chen Xin-yu Chen |
| author_sort | Jing Wang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-0898042c171c4871bebb53c6c69208d7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-0898042c171c4871bebb53c6c69208d72024-12-06T18:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-033731Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trialJing Wang0Cong Wang1Wen-jia Yang2Xin-tong Yu3Cong Fu4Jin-jin Li5Wen-lin Xu6Yi-xin Zheng7Yun-fei Chen8Xin-yu Chen9Department of Cardiology, Chinese PLA General Hospital, Beijing, ChinaDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaLaboratory Center of Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China6Eli Lilly and Company, Indianapolis, United States of AmericaBeijing University of Chinese Medicine Dongfang College, Beijing, ChinaIntroduction 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.https://bmjopen.bmj.com/content/10/3/e033731.full |
| spellingShingle | Jing Wang Cong Wang Wen-jia Yang Xin-tong Yu Cong Fu Jin-jin Li Wen-lin Xu Yi-xin Zheng Yun-fei Chen Xin-yu Chen Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial BMJ Open |
| title | Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial |
| title_full | Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial |
| title_fullStr | Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial |
| title_full_unstemmed | Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial |
| title_short | Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial |
| title_sort | acupuncture for insomnia with short sleep duration protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/3/e033731.full |
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