Abstract
IntroductionInsomnia 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.Methods and analysisA 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.Ethics and disseminationThis 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.Trial registrationChinese Clinical Trials Register ChiCTR1800015282.Protocol version: Version 1.0. Date: Dec.2020
Highlights
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
To the best of our knowledge, this is the first clinical trial to explore the influence of acupuncture on emotional network (EN) function
By analyzing the correlation between EN functional connectivity and clinical evaluation, we expect to reveal the neurological mechanism of spirit-regulating acupuncture treatment for ID
Summary
Study design This is a single-center, randomized, sham-controlled, observer- and patient-blinded trial involving two parallel groups using a 1:1 allocation ratio. Thirty age- and sexmatched healthy individuals who sleep well will be recruited as controls for the fMRI data analysis. A diagram of the trial design is provided in Fig. 1 and Table 1
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