NCT06730165

Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Bahçeşehir University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system neuromodulation. Hypotheses of the study: H0: Vagus nerve stimulation is more effective than trigeminal nerve simulation in terms of heart rate variability. H1: Trigeminal nerve stimulation is more effective than vagus nerve simulation in terms of heart rate variability.

Detailed description

In this study, 80 healthy participants (40 males, 40 females) aged between 20-50 years were randomized (www.randomizer.org) into four groups by computer software. After randomisation, one group was received transcutaneous vagus nerve stimulation inside the ear, while the other group was received trigeminal nerve stimulation above the ear.The third group received sham transcutaneous vagus nerve stimulation and the fourth group received sham trigeminal nerve simulation. Heart rate variability, pulse rate and blood pressure measurements were performed to determine which stimulation method is more effective. Heart rate variability was analysed with Kubios HRV programme after the 5-minute short measurement method. SNS, PNS and Stress Index and LF, HF and LF/HF parameters were evaluated in heart rate variability sub-parameters.

Conditions

• Autonomic Nervous System Imbalance

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Vagus Nerve Stimulation	Stimulation of the vagus nerve through the tragus and concha in the ear
DEVICE	Transcutaneous Auricular Trigeminal Nerve Stimulation	Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle

Timeline

• Start date: 2024-03-03
• Primary completion: 2024-04-01
• Completion: 2024-09-10
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: Turkey (Türkiye)