Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, 23 Art Museum Backstreet, Dongcheng District, Beijing, 100010, China.
Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
Trials. 2022 Jan 4;23(1):11. doi: 10.1186/s13063-021-05913-2.
Insomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trapped in a vicious circle of bad moods and poor sleep. Resting-state functional magnetic resonance imaging (r-fMRI) studies have shown abnormalities in emotion-related brain networks in patients with ID. And it has been proven that reducing negative emotions improves sleep quality. As a traditional alternative therapy, acupuncture has been demonstrated to be effective not only in improving sleep quality but also in stabilizing emotions; however, the mode of action needs to be further explored. Therefore, a clinical trial was designed to explore the effect of acupuncture in improving sleep and mood and to intuitively investigate the regulation of the emotional network using fMRI.
A total of 60 participants with ID will be randomly allocated to a spirit-regulating group or a control group using non-effective acupoints acupuncture at a ratio of 1:1. All participants will receive 3 acupuncture treatment sessions per week for 4 weeks. In addition, 30 healthy individuals will be included in the healthy group. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Hyperarousal Scale (HAS), and the Fatigue Scale-14 (FS-14), r-fMRI data, sleep diary, and actigraphy. The data will be collected prior to treatment, following treatment, and during the 12-week follow-up period; a sleep diary will be kept during the entire process.
This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital). The results will be published in peer-reviewed journals or presented at academic conferences.
Chinese Clinical Trials Register ChiCTR1800015282 . Protocol version: Version 1.0. Date: Dec.2020.
失眠障碍（ID）的特征是对睡眠的数量和质量不满意，常伴有焦虑和抑郁等负面情绪。失眠患者陷入情绪不佳和睡眠质量差的恶性循环。静息态功能磁共振成像（r-fMRI）研究表明，ID 患者的情绪相关脑网络存在异常。并且已经证明，减轻负面情绪可以改善睡眠质量。作为一种传统的替代疗法，针灸不仅在改善睡眠质量方面，而且在稳定情绪方面都被证明是有效的；然而，其作用模式仍需进一步探讨。因此，设计了一项临床试验，旨在探讨针灸改善睡眠和情绪的效果，并通过 fMRI 直观地研究情绪网络的调节。
共 60 名 ID 患者将采用非有效穴位针刺法以 1:1 的比例随机分为调神组和对照组。所有参与者每周接受 3 次针刺治疗，共 4 周。此外，将纳入 30 名健康个体作为健康组。主要结局是匹兹堡睡眠质量指数（PSQI）。次要结局是汉密尔顿焦虑量表（HAMA）、汉密尔顿抑郁量表（HAMD）、过度警觉量表（HAS）和疲劳量表-14（FS-14）、r-fMRI 数据、睡眠日记和活动记录仪。数据将在治疗前、治疗后和 12 周随访期间收集；整个过程中都将记录睡眠日记。
本方案已获得北京中医药大学东方医院研究伦理委员会的批准。研究结果将发表在同行评议的期刊上或在学术会议上展示。
中国临床试验注册中心 ChiCTR1800015282。方案版本：第 1.0 版。日期：2020 年 12 月。
Zotero 插件
