Breathing Exercises and Auricular Vagus Nerve Stimulation

NCT06531954 | Completed Phase 2

• 1 other identifier: Nervusvagus
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. In this study, we aimed to compare these two methods, which have similar effects. Methods: 88 healthy participants aged 18-35 were randomly divided into breathing exercises (Group BE) and vagus stimulation (Group VNS). Thoracic expansion exercise was performed in the BE group. In the VNS group, biphasic electrical stimulation was applied to both ears with a pulse width of 300 microseconds, frequency of 10 Hz, and 20 minutes. Pulmonary function tests were measured on the first and last day. Heart rate, systolic and diastolic blood pressure, RMSSD, PNN50, LF/HF, LF Power, and HF Power values were measured before and after each of the ten sessions for both groups.

Conditions

Breathing Exercises; Auricular Vagus Nerve Stimulation; Autonomic Nervous System

Keywords

Breathing Exercises; Autonomic Nervous System; Pulse Rate Variability; Respiratory Functions; Auricular Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (3)

• Autonomic nervous system activity

  Autonomic measurements of each individual participating in the study before and after the intervention were performed with heart rate variability parameters. For this purpose, the Elite HRV device was used. The device has a finger sensor and an application compatible with the phone. Elite HRV application is a software that can synchronize with a personal monitor by collecting peak-to-peak intervals for instant analysis of pulse rate variability (PRV). In addition to all these assessments, blood pressure measurements of the participants were also evaluated using an Omron M2 electronic sphygmomanometer on the right arm.

  pre-intervention, immediately after-intervention

• Pulmonary Function. Forced expiratory volume in the first second (FEV1)

  Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.

  pre-intervention, immediately after-intervention

• Pulmonary Function. Forced vital capacity (FVC)

  Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.

  pre-intervention, immediately after-intervention

Study Arms (2)

Breathing exercise group (BE)

ACTIVE COMPARATOR

The content of breathing exercises was planned as thoracic expansion exercises. These exercises were applied to the lower, middle, and upper lobes in 3 sets of 3x10 (90 times breathing in one area) and lasted for an average of 20 minutes. These exercises were first taught by the physiotherapist and performed under her supervision. Participants were asked to inhale as deeply as possible into the relevant area, hold their breath for 3 seconds, and then slowly exhale the entire breath.

Behavioral: Breathing exercise

Vagus nerve stimulation group (VNS)

EXPERIMENTAL

Vagus stimulation was applied bilaterally through the ear. taVNS was performed with the Vagustim device. The stimulation pulse width was 300 microseconds, the frequency was 10 Hz, and it was biphasic with a 20-minute duration. Electrodes were placed on the concha and tragus parts of the ear, and the current was increased through these electrodes until the participant felt pain. When the participant felt pain, the intensity was reduced to a comfortable sensation.

Device: Vagus nerve stimulation

Interventions

Vagus nerve stimulation DEVICE

Vagus nerve stimulation group: Vagus stimulation was applied bilaterally through the ear. taVNS was performed with the Vagustim device. The stimulation pulse width was 300 microseconds, the frequency was 10 Hz, and it was biphasic with a 20-minute duration. Electrodes were placed on the concha and tragus parts of the ear, and the current was increased through these electrodes until the participant felt pain.

Vagus nerve stimulation group (VNS)

Breathing exercise BEHAVIORAL

Breathing exercise group: The content of breathing exercises was planned as thoracic expansion exercises. These exercises were applied to the lower, middle, and upper lobes in 3 sets of 3x10 (90 times breathing in one area) and lasted for an average of 20 minutes. Participants were asked to inhale as deeply as possible into the relevant area, hold their breath for 3 seconds, and then slowly exhale the entire breath.

Breathing exercise group (BE)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals between the ages of 18 and 35,
• without orthopedic disability,
• without any chronic disease and regular medication use,
• who had not smoked for the last year,
• who had no problems in reading, writing, or comprehension were included in our study.

You may not qualify if:

• active or chronic respiratory diseases and communication problems because they may adversely affect pulmonary function testing

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Mudanya University

Bursa, 16160, Turkey (Türkiye)

Location

Related Publications (1)

• Hatik SH, Arslan M, Demirbilek O, Ozden AV. The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals. Brain Behav. 2023 Dec;13(12):e3332. doi: 10.1002/brb3.3332. Epub 2023 Nov 16.

  PMID: 37974551 RESULT

MeSH Terms

Interventions

Vagus Nerve Stimulation; Breathing Exercises

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The 88 volunteer cases were divided into two groups by randomization. By randomization, according to the order of participation in the study, odd-numbered people (such as first, third, fifth) were included in the breathing exercises group (Group BE); even-numbered people (such as second, fourth, sixth) were included in the vagus nerve stimulation group (Group VNS). After randomization, 44 cases in Group BE and 44 cases in Group VNS were evaluated. All participants completed the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Our study was conducted as a randomized prospective study. In both groups, the interventions were performed for ten sessions for two weeks, five days a week. In both groups, heart rate variability, heart rate, and blood tension were measured before and after each session, and the pulmonary function test was evaluated the day before and the day after the ten sessions of applications.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 1, 2024
• Study Start: January 2, 2021
• Primary Completion: January 3, 2022
• Study Completion: March 1, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: a year
• Access Criteria: nervus vagus stimulation

Locations

TU (1)