Actively Recruiting
Transcutaneous Electrical 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
25 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
Researchers are evaluating the effects of transcutaneous electrical stimulation of the auricular vagus nerve (TENS) on heart rate variability (HRV), a marker of autonomic nervous system activity. This study aims to determine a reliable biomarker for successful vagus nerve activation using TENS, which is a non-invasive alternative to invasive cervical vagus nerve stimulation used for depression, epilepsy, and other conditions. The trial addresses inconsistent data on how TENS affects HRV due to varied study methods and control conditions. The study compares two groups: one receiving active TENS applied to the tragus of the left ear at 20 Hz and 200 microseconds below discomfort threshold, and a sham group receiving similar stimulation at the left earlobe, which lacks vagus nerve innervation. Each stimulation lasts 10 minutes. Researchers will assess HRV parameters before stimulation, during two consecutive 5-minute intervals of stimulation, and after stimulation ends. Participants will undergo heart rate and HRV monitoring throughout the study periods. The main outcome measured is the change in the LF/HF ratio of HRV, evaluated at rest, during stimulation, and post-stimulation. Secondary outcomes include various HRV components and heart rate dynamics measured at the same intervals. The total participation spans these assessments, focusing on objective measures of autonomic response to TENS. The study is randomized and single-masked, involving adults aged 18 to 75 years with sinus rhythm.
CONDITIONS
Brief Title
Auricular Vagus Stimulation and Heart Rate Variability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have sinus rhythm at the time of registration
- Age between 18 and 75 years
- All genders are eligible
You will not qualify if you...
- Frequent ventricular or supraventricular extrasystole or second or third degree AV block
- Taking glucocorticosteroids within the last month
- Taking any antiarrhythmic medications except beta blockers
- Severe chronic kidney or liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 minutes
Participants receive transcutaneous electrical auricular vagus nerve stimulation (TENS) with either active or sham devices applied to the ear. Heart rate variability (HRV) parameters are evaluated before, during, and after the stimulation session.
1 visit (in-person)
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
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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