Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 15, 2025
Date Accepted: Dec 26, 2025
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
ABSTRACT
Background:
Insomnia seriously impairs daytime function and is closely related to autonomic dysfunction.
Objective:
This study is a randomized controlled trial to compare the effects of acupuncture based on meridian theory and conventional acupuncture on sleep quality and autonomic nerve function in patients with insomnia of liver depression and spleen deficiency.
Methods:
Ninety-six patients were randomly divided into two groups and compared with 48 healthy controls at baseline. The patients were treated for 4 weeks, 3 times a week.
Results:
The main outcome indicators were changes in the Pittsburgh Sleep Quality Index (PSQI) and the 36-Item Short-Form Health Survey (SF-36) scores. The data collection is expected to take place from July 2025 to November 2026, and 40 people have been collected. No data analysis has been started. The results are expected to be published between December 2026 and March 2027.
Conclusions:
The purpose of this study is to establish the efficacy of targeted acupuncture regimen, and to explore its mechanism of action through autonomic nerve regulation mechanism, so as to provide a basis for optimizing clinical strategies. Clinical Trial: Clinical Trial Registry:ClinicalTrials.gov PRS(Protocol Registration and ResultsSystem). ClinicalTrials.gov ID:NCT06782815. Registration Date : 2025-02-10.
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