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RECRUITING
NCT05680337
NA

Auricular Vagus Stimulation and Heart Rate Variability

Sponsor: Bakulev Scientific Center of Cardiovascular Surgery

View on ClinicalTrials.gov

Summary

Transcutaneous electrical stimulation of the auricular vagus nerve (TENS) is a promising method of neuromodulation of the autonomic nervous system in patients with various pathologies. The use of this method requires the determination of a reliable biomarker of successful activation of the vagus nerve using TENS. Currently, most studies focus on the assessment of heart rate variability (HRV) as a marker of the functioning of the autonomic nervous system. Despite the physiological justification of HRV as a biomarker for TENS, the data on the effects of TENS on HRV are ambiguous. In some studies, a significant decrease in the ratio of spectral characteristics (LF/HF) in active TENS was found in comparison with fictitious stimulation (sham), which indicated an increase in the parasympathetic component of HRV. However, other studies have not revealed an increase in HRV.

Official title: Transcutaneous Electrical Auricular Vagus Stimulation and Heart Rate Variability

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2022-12-01

Completion Date

2026-07-01

Last Updated

2025-06-18

Healthy Volunteers

Yes

Interventions

DEVICE

TENS

TENS stimulation will occur within 10 minutes. HRV parameters will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.

Locations (3)

Federal Center for Cardiovascular Surgery (Astrakhan)

Astrakhan, Russia

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

Krasnodar, Russia

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, Russia