Acupuncture for hypertension with insomnia: Study protocol for a randomized, sham-controlled, subject-and-assessor-blinded trial

BACKGROUND: Previous studies show that insomnia and hypertension are closely related. Currently, intervention for hypertension with insomnia has become a research hotspot. Acupuncture, as a representative non-pharmaceutical therapy of traditional Chinese medicine (TCM), has been widely used in improving insomnia and hypertension. However, there are few clinical studies on acupuncture for hypertension with insomnia. METHODS: A single-center, subject-and-assessor-blind, randomized, sham-controlled trial has been designed for a study to be conducted in Jiangsu Province Hospital of Chinese Medicine. Sixty eligible patients will be randomly assigned to the treatment group and the control group in a 1:1 ratio. The treatment group will receive acupuncture treatment, while the control group will receive sham acupuncture treatment. Both groups will be treated three times per week for 4 weeks. Data will be collected at baseline and after 4 weeks of treatment and analyzed by using SPSS 25.0. The primary outcome measures are sleep parameters of portable polysomnography before and after treatment. Secondary outcomes are Pittsburgh Sleep Quality Index, Insomnia Severity Index, home blood pressure, and heart rate variability. DISCUSSION: This study aims to evaluate the efficacy of acupuncture using the portable polysomnography combined with sleep scales, and analyze heart rate variability to preliminarily explore the underlying mechanism of acupuncture on hypertension with insomnia. The trail, if proven to be effective, will provide strong scientific evidence to support acupuncture is effective to manage patients for hypertension with insomnia. CLINICAL TRIAL REGISTRATION: ChiCTR2200059161.