Breathing Exercises and Auricular Vagus Nerve Stimulation

NCT ID: NCT06531954

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-02
• Study Completion Date: 2023-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Breathing exercise group (BE)

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.

Group Type: ACTIVE_COMPARATOR

Breathing exercise

Intervention Type: 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.

Vagus nerve stimulation group (VNS)

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.

Group Type: EXPERIMENTAL

Vagus nerve stimulation

Intervention Type: 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.

Interventions

Vagus nerve stimulation

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.

Intervention Type: DEVICE

Breathing exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

gulay karacaoglu

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mudanya University

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 37974551 (View on PubMed)

Other Identifiers

Nervusvagus

Identifier Type: -

Identifier Source: org_study_id