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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531954
Enrollment
88
Registered
2024-08-01
Start date
2021-01-02
Completion date
2023-03-01
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auricular Vagus Nerve Stimulation, Autonomic Nervous System, Breathing Exercises

Keywords

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

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.

Interventions

DEVICEVagus 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.

BEHAVIORALBreathing 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.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Autonomic nervous system activitypre-intervention, immediately after-interventionAutonomic 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.
Pulmonary Function. Forced expiratory volume in the first second (FEV1)pre-intervention, immediately after-interventionParticipants 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.
Pulmonary Function. Forced vital capacity (FVC)pre-intervention, immediately after-interventionParticipants 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026