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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TENS
DeviceTENS 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Active TENSActive comparator 1 intervention
Group B: Sham TENSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dynamics of LF/HF
Changes in the level of LF /HF relative to the initial and after the end of stimulation in the groups of active and fictitious stimulation
Time frame
This parameter 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.Secondary outcomes
1
HR dynamics
Changes in the HR level relative to the initial and after the end of stimulation in the groups of active and fictitious stimulation
Time frame
This parameter 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.2
Dynamics of SDNN
Changes in the level of SDNN relative to the initial and after the end of stimulation in the groups of active and fictitious stimulation
Time frame
This parameter 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.3
Dynamics of IVB
Changes in the level of IVB relative to the initial and after the end of stimulation in the groups of active and fictitious stimulation
Time frame
This parameter 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.4
Dynamics of IC1
Changes in the level of IC1 relative to the initial and after the end of stimulation in the groups of active and fictitious stimulation. IC1 (Index Centralization) = (HF+LF)/VLF
Time frame
This parameter 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 and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov