The Effects of Tai Chi on Insomnia Based on Multi-modal Brain Functional Connection and Signal Extraction: A Protocol for Randomized Controlled Trial v1

Background: Insomnia is a prevalent and costly disorder that poses a significant health burden and may be associated with abnormal brain functional connectivity. Tai Chi has shown promise as a non-pharmacological therapy in improving sleep quality in insomnia patients, but the underlying brain network mechanisms remain unclear. This study utilized advanced multimodal brain function analysis techniques, including resting-state functional magnetic resonance imaging (rs-fMRI) and functional near-infrared spectroscopy (fNIRS), to investigate how Tai Chi affects brain networks in individuals with insomnia. The research aims to assess the therapeutic effects of Tai Chi in different intervention cycles and to explore the potential for Tai Chi to become the preferred non-pharmacological treatment for insomnia. Methods: This study is designed as a parallel, single-blind, randomized controlled clinical trial (RCT) involving 36 participants. Eligible patients will be divided into three groups: Tai Chi group, Cognitive behavioral therapy for insomnia (CBTI) group and Health education group, in a 1:1:1 ratio with 12 subjects in each subgroup. The primary outcomes will be LC resting-state functional magnetic resonance imaging (rs-fMRI); Hemoglobin (HbO) and deoxyhemoglobin (HbR) of the prefrontal cortex (PFC) will be measured by functional near-infrared spectroscopy (fNIRS). The secondary outcomes will be pittsburgh sleep quality index (PSQI), insomnia severity index (ISI), and hamilton anxiety scale (HAMA). Outcomes will be evaluated at baseline, 4, 8, and 12-week post treatment, as well as at 4-week follow-up. Discussion: This study is the first randomized controlled trial to investigate the effects of Tai Chi on insomnia by incorporating multimodal information such as brain functional connectivity signals and cerebral oxygenation signals, aiming to assess the therapeutic efficacy of Tai Chi on insomnia and to clarify its intervention mechanism. This study has the potential to significantly impact the field of insomnia treatment and sleep disorder research by providing valuable insights into the therapeutic effects of Tai Chi. Trial Registration: The study protocol has been registered in the China Clinical Trial Registry (ChiCTR2300077348).