Acupuncture for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial
Acupuncture for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial
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使用静息态功能磁共振成像针灸治疗失眠症患者：随机对照试验方案
DOI：
10.1186/s13063-019-3836-z
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发表时间：
2019-12-09
期刊：
影响因子：
2.5
通讯作者：
Li, Bin
中科院分区：
文献类型：
--
作者：
Guo, Jing;Yu, Siyi;Li, Bin
背景失眠是最常见的睡眠相关障碍之一。失眠症与大脑过度觉醒状态相关，表现为异常的区域大脑活动和静息状态功能连接。针灸可以改善睡眠质量并调节过度觉醒状态;然而，改善睡眠质量的潜在神经生物学基础却知之甚少。本临床试验的目的是研究针刺治疗失眠症的疗效。此外，针灸影响失眠症的神经机制将探讨使用静息态功能磁共振成像（rs-fMRI）和neuropsychological parameters.Methods和designA随机，患者和评估者盲法试验将进行。我们将60名符合条件的失眠症患者随机（按1：1的比例）分为真实的针灸组和假针灸组。干预措施将在4周内每周进行3次，随访期为8周。健康对照组由30名年龄和性别匹配的健康个体组成，他们睡眠良好，没有任何治疗干预。所有参与者都将接受神经心理学和rs-fMRI评估。匹兹堡睡眠质量指数（PSQI）评分的变化是主要结局参数。次要结果参数包括过度觉醒量表（HAS）、rs-fMRI测量、疲劳量表-14（FS-14）、汉密尔顿抑郁量表（HAMD）、汉密尔顿焦虑量表（HAMA）、睡眠日记和活动记录仪。分析将基于意向治疗实施。DiscussionThe研究结果将用于阐明针灸改善失眠症患者睡眠质量的有效性和机制。试验注册中国临床试验注册，ChiCTR 1800015282。于2018年3月20日注册。
BackgroundInsomnia is among the most prevalent of the sleep-related disorders. Insomnia disorder is associated with a brain hyperarousal state manifested by abnormal regional brain activity and resting state functional connectivity. Acupuncture improves sleep quality and modulates the hyperarousal state; however, the underlying neurobiological basis for improved sleep quality is poorly understood. The purpose of this clinical trial is to study the efficacy of acupuncture in the treatment of insomnia disorder. In addition, the neural mechanism by which acupuncture affects insomnia disorder will be explored using resting-state functional magnetic resonance imaging (rs-fMRI) and neuropsychological parameters.Methods and designA randomized, patient- and assessor-blinded trial will be conducted. We will randomize (in a 1:1 ratio) 60 eligible patients with insomnia disorder into a real acupuncture group or a sham acupuncture group. Interventions will be administered three times per week over a 4-week period, with an 8-week follow-up period. The healthy control group will consist of 30 age- and sex-matched healthy individuals who sleep well without any treatment intervention.All participants will undergo neuropsychological and rs-fMRI evaluations. The change in Pittsburgh Sleep Quality Index (PSQI) scores is the primary outcome parameter. The secondary outcome parameters include the Hyperarousal scale (HAS), rs-fMRI measurements, the Fatigue scale-14 (FS-14), the Hamilton depression scale (HAMD), the Hamilton anxiety scale (HAMA), a sleep diary, and an actigraph.Assessment of all parameters will be performed at baseline, post-treatment, and during follow-up. Analyses will be implemented based on intention-to-treat.DiscussionThe study results will be used to clarify the effectiveness and elucidate the mechanism by which acupuncture improves sleep quality in patients with insomnia disorder.Trial registrationChinese Clinical Trials Register, ChiCTR1800015282. Registered on 20 March 2018.