Auricular Vagus Stimulation and Heart Rate Variability

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBakulev Scientific Center of Cardiovascular Surgery

About this trial

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.

Eligibility criteria

Qualifiers

Sinus rhythm at the time of registration

Disqualifiers

Frequent ventricular / supraventricular extrasystole, 2d/3d degree AV Block

Taking glucocorticosteroids in the last 1 month

Taking any antiarrhythmics, except beta blockers

Severe chronic renal or liver pathology

Trial design

Treatments tested in this trial

  • TENS

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Bakulev Scientific Center of Cardiovascular Surgery

Lead sponsor

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

Collaborator

Astrakhan Federal Centre For Cardiac Surgery

Collaborator