Actively Recruiting
Auricular Vagus Stimulation and Heart Rate Variability
Led by Bakulev Scientific Center of Cardiovascular Surgery · Updated on 2025-06-18
600
Participants Needed
3
Research Sites
186 weeks
Total Duration
On this page
Sponsors
B
Bakulev Scientific Center of Cardiovascular Surgery
Lead Sponsor
S
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Auricular Vagus Stimulation and Heart Rate Variability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sinus rhythm at the time of registration
You will not qualify if you...
- Frequent ventricular or supraventricular extrasystole, or 2nd/3rd degree AV block
- Taking glucocorticosteroids in the last 1 month
- Taking any antiarrhythmics, except beta blockers
- Severe chronic renal or liver pathology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Federal Center for Cardiovascular Surgery (Astrakhan)
Astrakhan, Russia
Actively Recruiting
2
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Krasnodar, Russia
Actively Recruiting
3
Bakulev National Medical Research Center for Cardiovascular Surgery
Moscow, Russia, 121552
Actively Recruiting
Research Team
V
Vladimir Shvartz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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