Breathing Exercises and Auricular Vagus Nerve Stimulation
NCT Number: NCT06531954
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breathing Exercises|Auricular Vagus Nerve Stimulation|Autonomic Nervous System
Interventions: DEVICE: Vagus nerve stimulation|BEHAVIORAL: Breathing exercise
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-01-02
Completion Date: 2023-03-01
Locations: Mudanya University, Bursa, 16160, Turkey

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.

Primary Outcome Measures: Autonomic nervous system activity, Autonomic 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., pre-intervention, immediately after-intervention|Pulmonary Function. Forced expiratory volume in the first second (FEV1), Participants 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., pre-intervention, immediately after-intervention|Pulmonary Function. Forced vital capacity (FVC), Participants 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., pre-intervention, immediately after-intervention