Clinical trial NCT06531954: Breathing Exercises and Auricular Vagus Nerve Stimulation
Official title: Comparison Of Breathing Exercises and Auricular Vagus Nerve Stimulation Effects On Autonomic Nervous System Activity and Respiratory Functions In Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Autonomic nervous system activity
timeFrame: pre-intervention, immediately after-intervention
measure: Pulmonary Function. Forced expiratory volume in the first second (FEV1)
timeFrame: pre-intervention, immediately after-intervention
measure: Pulmonary Function. Forced vital capacity (FVC)
timeFrame: pre-intervention, immediately after-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Mudanya University
Study officials:
References:
citation: Hatik SH, Asrlan 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.