Bilateral transcutaneous auricular vagus nerve stimulation for the treatment of insomnia in breast cancer.

Substantial diagnostic and therapeutic advances have been made in medicine to address breast cancer. There remain unmet needs to translate solutions for addressing insomnia and mental health concerns in breast cancer patients. In this open-label, pilot clinical trial, we evaluated the safety and efficacy of nightly, bilateral, transcutaneous auricular vagus nerve stimulation (taVNS) on insomnia and mental health outcomes in breast cancer patients across a two-week treatment period. Our results demonstrate that noninvasive vagus nerve stimulation can significantly reduce insomnia severity, improve sleep quality, decrease sleep onset latency, and enhance sleep efficiency. Treatment with taVNS also significantly reduced the number of nightly awakenings, cancer-related fatigue, and depression scores while increasing heart rate variability. These observations demonstrate that auricular vagus nerve stimulation holds promise for improving sleep quality and mental health in patients diagnosed with breast cancer. Future investigations aimed at more thoroughly investigating the safety profile and clinical impacts of taVNS on the quality of life in patients with breast cancer are warranted.ClinicalTrials.gov Identifier: NCT06006299 23/08/2023.