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Auricular Vagus Stimulation and Heart Rate Variability

NCT05680337 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-06-18

No results posted yet for this study

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.

Conditions

  • Vagus Nerve Stimulation
  • Heart Rate Variability

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.

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Astrakhan Federal Centre For Cardiac Surgery

    collaborator OTHER

  • Bakulev Scientific Center of Cardiovascular Surgery

    lead OTHER_GOV

Principal Investigators

  • Vladimir Shvartz · Bakoulev Scientific Center for Cardiovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2026-01-01
Completion
2026-07-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05680337 on ClinicalTrials.gov