Transcutaneous Vagus Nerve Stimulation for Insomnia in People Living in Places or Cities with High Altitudes: A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to investigate the effectiveness and safety of transcutaneous vagus nerve stimulation (tVNS) to improve insomnia in the special environment of a plateau. METHODS: This study was a single-center, single-blind, randomized controlled trial. A total of 100 patients with insomnia at high altitude were randomized into three groups receiving either transcutaneous vagus nerve stimulation intervention in the left ear tragus (treatment group), pseudo-stimulation intervention (sham group), or cognitive behavioral therapy for insomnia (CBTI group). The primary measure was the Pittsburgh Sleep Quality Index (PSQI) score. In addition, we assessed the patients' objective sleep status with polysomnography and evaluated changes in the Insomnia Severity Index Scale (ISI) and Generalized Anxiety Disorder-7 (GAD-7) scores. We used one-way ANOVA and repeated-measures ANOVA for analysis. RESULTS: Patients' PSQI, ISI, and GAD-7 scale scores significantly decreased after 4 weeks of tVNS treatment and were greater than those of the control group. Polysomnographic data also demonstrated shortened sleep latency and longer deep sleep in the patients. CONCLUSION: tVNS is effective in improving sleep quality and reducing anxiety levels in high-altitude insomnia patients but should be confirmed in future adequate and prolonged trials to guide clinical promotion.