Effects of transcutaneous auricular vagus nerve stimulation on patients with post-stroke insomnia: a randomized controlled trial protocol - Report - MDSpire

Effects of transcutaneous auricular vagus nerve stimulation on patients with post-stroke insomnia: a randomized controlled trial protocol

  • By

  • Jifei Sun

  • Siyan Chen

  • Chenjie Ma

  • Hongwei Liu

  • Yuan Zhou

  • Haoran Gao

  • Kexin Ma

  • Xiaojian Zhang

  • Xue Xiao

  • June 29, 2026

  • 0 min

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Clinical Report: Investigating the Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Insomnia in Post-Stroke Patients

Background

Post-stroke insomnia is a prevalent complication affecting over 50% of stroke survivors, significantly impacting their recovery and quality of life. Current treatment options, including sedative-hypnotics and cognitive behavioral therapy, have limitations. taVNS has shown potential in treating insomnia and related conditions, but evidence specifically for post-stroke insomnia is limited.

Data Highlights

This study will enroll 48 patients with post-stroke insomnia, randomly assigned to either a taVNS or sham-taVNS group, with interventions administered daily for four weeks. Primary outcomes include MRI indicators such as resting-state functional MRI and cerebral blood flow. Secondary outcomes involve clinical efficacy scales like the Pittsburgh Sleep Quality Index and the Hamilton Depression Rating Scale, assessed at multiple time points.

Key Findings

  • Post-stroke insomnia affects approximately 50% of stroke survivors.
  • Current treatments for insomnia in stroke patients have limitations, including risks of tolerance and dependence.
  • taVNS has demonstrated potential in treating insomnia and post-stroke depression.
  • This trial aims to provide evidence for the efficacy of taVNS in treating post-stroke insomnia.
  • Multimodal MRI will be used to assess changes in brain function and structure.

Clinical Implications

The findings from this trial may inform the clinical application of taVNS for managing insomnia in post-stroke patients.

Conclusion

This study seeks to address the evidence gap regarding the use of taVNS for post-stroke insomnia.

Related Resources & Content

  1. BMC Psychiatry, 2025 -- Forecasting therapeutic outcomes of transcutaneous auricular vagus nerve stimulation in individuals with insomnia
  2. Frontiers in Neurology, 2026 -- Effectiveness of transcutaneous auricular vagus nerve stimulation in stroke rehabilitation
  3. Development of insomnia in patients with stroke: A systematic review and meta-analysis, 2024
  4. Combination treatment for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline, 2025
  5. Frontiers in Neurology — Ultrasound-guided stellate ganglion acupuncture for chronic insomnia disorder using fNIRS: study protocol for a randomized controlled trial
  6. Frontiers in Psychiatry — Auricular acupuncture for insomnia in female patients with non-metastatic breast cancer: study protocol for a multicenter, randomized, controlled clinical trial
  7. American Stroke Association Guidance on Post-Stroke Insomnia
  8. Combination treatment for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline | Journal of Clinical Sleep Medicine | Springer Nature Link
  9. Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Insomnia Disorder

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