Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise

December 13, 2024 updated by: Istanbul Gelisim University

Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise on the Autonomic Nervous System Activity and Biomechanical Properties of the Muscle in Healthy People

The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults.

Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic system will be compared for both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Avcılar
      • Istanbul, Avcılar, Turkey, 34310
        • İstanbul Gelisim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • could read and write Turkish

Exclusion Criteria:

  • being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: autonomic function
Other: Transcutaneous vagus nerve stimulation
Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together
Other: Deep breath exercise
Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together
Active Comparator: somatic function
Other: Transcutaneous vagus nerve stimulation
Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together
Other: Deep breath exercise
Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRV results
Time Frame: 5 minutes
Measuring autonomic values for 5 minutes
5 minutes
Muscle Natural Oscillation Frequency
Time Frame: 5 minutes
Biomechanical measurements of specific muscles
5 minutes
Muscle Dynamic Stiffness [N/m]
Time Frame: 5 minutes
measured using the myoton device
5 minutes
Mechanical Stress Relaxation Time [ms]
Time Frame: 5 minutes
measured using the myoton device
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress scale
Time Frame: 5 minutes
Evaluation of stress levels with the specified questionnaire
5 minutes
Pulse rate
Time Frame: 5 minutes
Measuring with a sphygmomanometer
5 minutes
blood pressure
Time Frame: 5 minutes
Measuring blood pressure with a sphygmomanometer
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Gelisim University

Collaborators

Bahçeşehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2022

Primary Completion (Actual)

June 12, 2022

Study Completion (Actual)

August 28, 2022

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNS06.01.2022/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vagus Nerve Stimulations

Clinical Trials on Transcutaneous vagus nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe