Exploring the effects of low-level stimulation on the vagus nerve for heart conditions
The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function
This study is testing if a gentle electrical stimulation on a nerve in the ear can help people with atrial fibrillation and heart failure feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT04682704 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of low-level transcutaneous vagus nerve stimulation (LLTS) on autonomic nervous system function in patients with atrial fibrillation and heart failure. LLTS delivers electrical impulses to the auricular branch of the vagus nerve, which has shown promise in reducing inflammation and arrhythmias. The research aims to determine the optimal stimulation parameters for LLTS to maximize its therapeutic effects. Previous findings suggest that LLTS can significantly shorten atrial fibrillation duration and improve heart rate variability, making it a potential non-pharmacological treatment option.
Who should consider this trial
Good fit: Ideal candidates include adults over 21 with paroxysmal atrial fibrillation or heart failure with preserved ejection fraction.
Not a fit: Patients with recent strokes, significant heart failure, or other serious conditions affecting the autonomic nervous system may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-invasive treatment for patients with atrial fibrillation and heart failure.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female patients older than 21 year old 2. Healthy volunteers free from diagnosis of AF, heart failure, coronary artery disease or diseases that affect the autonomic nervous system. 3. Patients with Paroxysmal Atrial Fibrillation 4. Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) Exclusion Criteria: 1. Recent (\<6 months) stroke 2. Recent (\<6 months) myocardial infarction 3. Heart failure (NYHA class III or IV) 4. Left ventricular ejection fraction \<50% 5. Recurrent vaso-vagal syncopal episodes 6. Unilateral or bilateral vagotomy 7. Pregnancy or breast feeding 8. Uncontrolled diabetes or hypertension 9. Inability or unwillingness to understand and/or sign informed consent 10. Any serious disease that affects autonomic nervous system function 11. Any medications that affect autonomic nervous system function
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Stavrakis, MD, PhD — University of Oklahoma
- Study coordinator: Karrie Meeks
- Email: karrie-meeks@ouhsc.edu
- Phone: 4052714742
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.