Using electrical stimulation of the ear to improve heart rate variability
Transcutaneous Electrical Auricular Vagus Stimulation and Heart Rate Variability
This study is testing whether using electrical stimulation on the ear can help improve heart rate variability in people, which might lead to better treatments for conditions like depression and chronic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bakulev Scientific Center of Cardiovascular Surgery Government |
| Locations | 3 sites (Astrakhan and 2 other locations) |
| Trial ID | NCT05680337 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous electrical stimulation of the auricular vagus nerve on heart rate variability, a potential biomarker for autonomic nervous system function. Participants will receive low-frequency electrical impulses aimed at modulating vagal activity, which may provide a non-invasive alternative to traditional vagus nerve stimulation methods. The study aims to clarify the ambiguous data surrounding the relationship between this stimulation technique and heart rate variability, which has implications for various health conditions. By determining a reliable biomarker for successful vagus nerve activation, the research could enhance treatment strategies for conditions like depression and chronic pain.
Who should consider this trial
Good fit: Ideal candidates include individuals with sinus rhythm who are seeking alternative treatments for conditions like depression or chronic pain.
Not a fit: Patients with frequent ventricular or supraventricular extrasystole, advanced AV block, or severe chronic renal or liver pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive treatment option for patients with conditions related to autonomic nervous system dysfunction.
How similar studies have performed: While some studies have shown positive effects of similar stimulation techniques, the relationship between TENS and heart rate variability remains under investigation and is not yet fully established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sinus rhythm at the time of registration Exclusion Criteria: * 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
Where this trial is running
Astrakhan and 2 other locations
- Federal Center for Cardiovascular Surgery (Astrakhan) — Astrakhan, Russia (Recruiting)
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital — Krasnodar, Russia (Recruiting)
- Bakulev National Medical Research Center for Cardiovascular Surgery — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Vladimir Shvartz — Bakoulev Scientific Center for Cardiovascular Surgery
- Study coordinator: Vladimir Shvartz
- Email: vashvarts@bakulev.ru
- Phone: +79032619292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.