Clinical trial NCT07000175: Comparison of Heart Rate Variability Measurement on the Arm and Chest in Vagus Nerve Stimulation
Official title: Comparison of Heart Rate Variability Measurement on the Arm and Chest in Transcutaneous Auricular Vagus Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sympathetic; Imbalance
Keywords: Heart Rates
Vagus Nerves
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2025-06-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A modelling will be created in which the same intervention will be applied to the three groups but the evaluations will be made differently.
Primary purpose: SCREENING

Brief summary: Healthy participants will be included in this study by invitation and randomised into three groups. Participants in each group will receive bilateral transcutaneous vagus nerve stimulation with the same frequency, current transit time and current intensity. Heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, the differences between the groups in heart rate variability parameters (time-dependent, frequency-dependent) will be compared. The aim of this study is to examine the differences between heart rate variability measurements measured at different sites.

Detailed description: Heart rate variability is defined as the change in beat-to-beat interval, and the sympathetic and parasympathetic nervous system influences the change in beat-to-beat interval through cardiovascular connections. Heart rate variability measurement can be obtained by different methods. However, which method is more effective is controversial. The aim of this study was to investigate the differences between heart rate variability parameters measured on the chest, right arm and left arm.

Healthy participants aged 18-45 years will be included in the study. The inclusion criteria will be determined as being 18 years of age or older and not having any acute or chronic disease. Exclusion criteria will be determined as being previously involved in any neuromodulation intervention, smoking or alcohol use, and regular medication use.

Participants included in the study will be randomised into three groups and transcutaneous vagus nerve stimulation will be applied. The duration of treatment will be 20 minutes and single session stimulation will be performed. Current intensity, current passage time and frequency will be planned to be the same in each patient. Before and after stimulation, heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, heart rate variability parameters (time-dependent, frequency-dependent) will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* To know how to read and write Turkish
* Not having any acute or chronic disease

Exclusion Criteria:

* Previous application of any neuromodulation method
* Smoking or alcohol use
* Use of any supplementary medication

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Baseline and after 20 minutes of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Avrasya University Physical Therapy Laboratory
state: Ortahisar
Study officials:
affiliation: Igdir University
name: Ramazan Cihad Yılmaz, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. doi: 10.1249/MSS.0000000000001284.