Ning Yanzhe, Liu Xueyan, Yao Hao, Chen Pei, Li Xue, Jia Hongxiao
The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.
Department of Acupuncture and Moxibustion, Dongfang Hospital affiliated to Beijing University of Chinese Medicine, Beijing100078, China.
Medicine (Baltimore). 2020 Sep 4;99(36):e22068. doi: 10.1097/MD.0000000000022068.
Nearly 20% of night shift nurses will cause shift work disorder (SWD) due to the disruption of sleep-wake cycle, which not only affects the daily work efficiency, but also brings a huge burden on physical and mental health. Acupuncture is a safe and effective intervention on SWD. This trial will combine with functional magnetic resonance imaging (fMRI) to study the clinical effects and potential mechanism of acupuncture in the treatment of SWD.
This is a randomized controlled neuroimaging trial, with enrolled participants, outcome assessors, and data statisticians blinded. 60 patients with SWD and 30 healthy controls who sleep regularly will be recruited and divided into divided into a control group, a true acupoints treatment group (TATG) and a sham acupoints treatment group (SATG) by the ratio of 1:1:1. The TATG and SATG will receive 8 sessions of acupuncture treatment in 4 weeks. Cognitive function scales and MRI scanning will be performed before and after 4-week acupuncture treatment. The control group will receive no intervention. Functional connectivity of intra-network and inter-network will be the primary outcome and effect indicator. The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale. Neuroimage indicators will be correlated with clinical data and scores of cognitive function assessment to explore the possible mechanisms underlying the changes of brain activity caused by acupuncture treatment.
The results of this study will enable us to verify the therapeutic effect of acupuncture on SWD and explore the potential central mechanism of acupuncture on SWD from the change of brain activity.
近20%的夜班护士因睡眠-觉醒周期紊乱会导致轮班工作障碍（SWD），这不仅影响日常工作效率，还会给身心健康带来巨大负担。针灸是一种治疗SWD安全有效的干预措施。本试验将结合功能磁共振成像（fMRI）研究针灸治疗SWD的临床疗效及潜在机制。
这是一项随机对照神经影像学试验，研究对象、结果评估者和数据统计人员均采用盲法。将招募60例SWD患者和30例睡眠规律的健康对照者，按1:1:1的比例分为对照组、真穴治疗组（TATG）和假穴治疗组（SATG）。TATG和SATG将在4周内接受8次针灸治疗。在4周针灸治疗前后进行认知功能量表和MRI扫描。对照组不接受任何干预。网络内和网络间的功能连接性将作为主要结局和疗效指标。次要结局包括可重复神经心理状态评估量表、注意力网络测试、匹兹堡睡眠质量指数量表和针感评估量表。神经影像指标将与临床数据及认知功能评估得分相关联，以探索针灸治疗引起脑活动变化的可能机制。
本研究结果将使我们能够验证针灸对SWD的治疗效果，并从脑活动变化方面探索针灸治疗SWD的潜在中枢机制。
