Study on the curative effect and autonomic nerve function of primary insomnia patients with liver depression and spleen deficiency type based on acupoint selection of meridian theory: A Randomized Controlled Trial Protocol (Preprint)

UNSTRUCTURED Based on the theory of meridians and collaterals in traditional Chinese medicine, especially the theory of ' Lingshu · Jingbie ', this study regulates the function of autonomic nervous system and improves the symptoms of insomnia patients with liver depression and spleen deficiency by acupuncture at Tianrong(TE 16), Tianyou(SI 17) and other acupoints. Its core principles include regulating qi and blood of meridians, balancing yin and yang, and dredging meridians to improve sleep quality. From the perspective of modern medicine, acupuncture can regulate neurotransmitter levels ( such as GABA and Glu ), reduce sympathetic excitability, and relieve insomnia. Methods: Ninety-six outpatients with primary insomnia will be recruited from the Third Affiliated Hospital of Zhejiang Chinese Medical University. Participants will be randomized (1:1) into an acupuncture group (AG) and a conventional acupuncture control group (CG). Forty-eight healthy volunteers without sleep disorders will serve as a blank control group (HG). Interventions will be administered three times weekly for four weeks. Primary outcomes include the Pittsburgh Sleep Quality Index (PSQI) and the 36-Item Short Form Health Survey (SF-36). Secondary outcomes encompass the Insomnia Severity Index (ISI), Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS-16), and neurotransmitter levels (GABA, Glx). The study has been approved by the Ethics Committee of Zhejiang Chinese Medical University (Approval No.ZSLL-KY-2024-032-01). This approval ensures that the study adheres to ethical standards and protects the rights and safety of participants. Results will be shared with participants, researchers, and the public via conferences, publications, and online platforms. Findings will be submitted to a peer-reviewed journal. Trial Registration: Clinical Trial Registry:ClinicalTrials.gov PRS(Protocol Registration and ResultsSystem). ClinicalTrials.gov ID:NCT06782815. Registration Date : 2025-02-10.