Skip to main content
OpenTrials
Completed

NCT Number: NCT06730165

Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autonomic Nervous System Imbalance

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avrasya University

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be 18 years of age or older,
  • Not having any acute or chronic disease.

Exclusion criteria

  • Having any acute or chronic disease,
  • Having previously undergone vagus nerve stimulation or trigeminal nerve stimulation.

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

Stimulation of the vagus nerve through the tragus and concha in the ear

Transcutaneous Auricular Trigeminal Nerve Stimulation

Device

Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle

Primary outcomes

  1. Heart Rate Variability

    Time frame: Pre-intervention and immediately after the intervention

    5 minutes of heart rate variability was measured.

Secondary outcomes

  1. Systolic and Diastolic Blood Pressure

    Time frame: Pre-intervention and immediately after the intervention

    Systolic and diastolic blood pressure was measured with an electronic blood pressure monitor.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.