The fMRI Study for Acupuncture on Shift Work Sleep Disorder: Study Protocol for a Randomized Controlled Neuroimaging Trial

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Main idea: The results of this study will enable us to verify the therapeutic effect of acupuncture on shift work disorder and explore the potential central mechanism of acupuncture on shift work disorder from the change of brain activity.

Abstract

Nearly 20% of night shift nurses have shift work disorder (SWD) due to the disruption of the 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 shift work disorder. This trial will combine with functional magnetic resonance imaging (fMRI) to study the clinical effects and potential mechanism of acupuncture in the treatment of shift work disorder.

Methods and analysis: 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 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.

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