Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Laboratory Center of Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
BMJ Open. 2020 Mar 4;10(3):e033731. doi: 10.1136/bmjopen-2019-033731.
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.
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.
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.
ChiCTR1900023473; Pre-results.
睡眠持续时间短的失眠对患者健康的负面影响更为严重。现有文献表明，与认知行为疗法相比，药物治疗对这种失眠表型更为有效。然而，催眠药物的潜在副作用阻碍了它们的临床应用。针灸已广泛用于治疗失眠，但对于睡眠持续时间短的失眠是否具有治疗效果仍不清楚。本试验旨在评估针灸治疗睡眠持续时间短的失眠的疗效和安全性。
本研究设计为一项随机、单中心、单盲、安慰剂对照的临床试验，共纳入 152 名参与者。根据客观总睡眠时间，将符合条件的患者分为两组：正常睡眠时间失眠组和睡眠持续时间短的失眠组。然后，每组患者将随机分为两组，治疗组（针灸）和对照组（假针灸），每组 38 例。主要结局是匹兹堡睡眠质量指数和失眠严重程度指数。次要结局是活动记录仪、贝克焦虑量表、贝克抑郁量表和疲劳严重程度量表。所有不良反应将通过治疗突发症状量表进行评估。结果将在基线、治疗后以及 1 周和 1 个月随访时进行评估。
本方案已获得岳阳中西医结合医院伦理委员会的批准（编号：2019-17）。将从所有参与者处获得书面知情同意。研究结果将通过同行评议期刊发表传播。
ChiCTR1900023473；预注册。
