Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

Not Applicable

Completed

• Conditions: Autonomic Nervous System Imbalance

• Registration Number: NCT06730165
• Lead Sponsor: Bahçeşehir University

Brief 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.

Study Timeline

• Study Start: 2024-03-03
• Primary Completion: 2024-04-01
• Study Completion: 2024-09-10
• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	Pre-intervention and immediately after the intervention	5 minutes of heart rate variability was measured.

Secondary Outcome Measures

Name	Time	Method
Systolic and Diastolic Blood Pressure	Pre-intervention and immediately after the intervention	Systolic and diastolic blood pressure was measured with an electronic blood pressure monitor.

Trial Locations

Locations (1)

Avrasya University; 🇹🇷 Trabzon, Ortahisar, Turkey