Breathing Exercises and Auricular Vagus Nerve Stimulation

Medipol Health Group

Status and phase: Completed; Phase 2

Conditions: Auricular Vagus Nerve Stimulation; Breathing Exercises; Autonomic Nervous System

Treatments: Behavioral: Breathing exercise; Device: Vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06531954

Nervusvagus

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Breathing exercise group (BE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Breathing exercise

Vagus nerve stimulation group (VNS)

Experimental group

Description:

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.

Treatment:

Device: Vagus nerve stimulation