Neuroregulatory and clinical efficacy of auricular vagus nerve stimulation in elderly patients with chronic insomnia comorbid with functional dyspepsia: protocol for a randomized controlled trial

作者：Hao Zhou, Xing Tang, Dan Wang, Zubo Huang, Yue Zeng, Shanshan Liu, Wang Chao · 发表于：Frontiers in Medicine · 年份：2025 · DOI：10.3389/fmed.2025.1537515 · 被引用次数：6 · 研究领域：Vagus Nerve Stimulation Research、Gastrointestinal motility and disorders、Respiratory and Cough-Related Research

Objective This study innovatively employs transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive physical therapy, to intervene in elderly patients with chronic insomnia (CI) comorbid with functional dyspepsia (FD). Through systematic investigation of the molecular mechanisms underlying vagus nerve pathway regulation in ameliorating intestinal inflammatory microenvironment and modulating central neurotransmitter homeostasis, this research aims to provide a novel, neuromodulation-based precision therapeutic approach characterized by favorable safety and tolerability for integrated management of geriatric comorbidities. Methods/design This double-blind randomized controlled trial will enroll 60 elderly patients (60–85 years) meeting ICSD-3 criteria for CI and Rome IV criteria for FD. Using block randomization with computer-generated sequences, eligible participants will be allocated 1:1 to either active taVNS group ( n = 30) or sham control group ( n = 30). The CFDA-certified transcutaneous vagus nerve stimulator (Model tVNS501, Reach Medical, China; Registration No. SuXieZhun20212090050) will be positioned at standardized anatomical sites: the concha cymba (the inferior margin of the intersection between the superior and inferior crura of the antihelix within the cymba conchae), electrical stimulation will deliver with fixed parameters (frequency: 80 Hz, pulse width: 100 μs, pulse 40–60s). The active group will receive validated taVNS parameters, while the sh...