Clinical Trials Directory

Trials / Completed

CompletedNCT06531954

Breathing Exercises and Auricular Vagus Nerve Stimulation

Comparison Of Breathing Exercises and Auricular Vagus Nerve Stimulation Effects On Autonomic Nervous System Activity and Respiratory Functions In Healthy Adults

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Istanbul Medipol University Hospital · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICEVagus nerve stimulationVagus 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.
BEHAVIORALBreathing exerciseBreathing 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.

Timeline

Start date
2021-01-02
Primary completion
2022-01-03
Completion
2023-03-01
First posted
2024-08-01
Last updated
2024-08-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06531954. Inclusion in this directory is not an endorsement.