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NCT05680337
Auricular Vagus Stimulation and Heart Rate Variability
Conditions: Vagus Nerve Stimulation, Heart Rate Variability
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 600
Sponsor: Bakulev Scientific Center of Cardiovascular Surgery
Location: Russian Federation
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.
Eligibility Criteria
Inclusion Criteria:Sinus rhythm at the time of registrationExclusion Criteria:Frequent ventricular / supraventricular extrasystole, 2d/3d degree AV BlockTaking glucocorticosteroids in the last 1 monthTaking any antiarrhythmics, except beta blockersSevere chronic renal or liver pathology
Source: ClinicalTrials.gov (NCT05680337). StuddyBuddy aggregates publicly available trial information.