The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function
Launched by UNIVERSITY OF OKLAHOMA · Dec 18, 2020
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to help manage heart conditions like atrial fibrillation (AF) and heart failure by using a technique called low-level transcutaneous vagus nerve stimulation (LLTS). This involves sending small electrical signals to a specific nerve in the ear, which has been shown to help reduce inflammation and improve heart function. The study will test two different settings of LLTS to see how they affect heart health and the body's response to stress in both healthy volunteers and patients with AF or heart failure.
To participate in this trial, you need to be over 21 years old, and you can either be a healthy volunteer or someone with paroxysmal atrial fibrillation or heart failure with preserved ejection fraction. Unfortunately, certain health conditions, such as recent strokes, severe heart failure, or pregnancy, would make you ineligible. If you join, you’ll receive LLTS for about 15 minutes, and researchers will measure how your heart and body respond before and after the treatment. This study is an exciting opportunity to explore a non-drug approach to improving heart health!
Gender
ALL
Eligibility 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
About University Of Oklahoma
The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oklahoma City, Oklahoma, United States
Patients applied
Trial Officials
Stavros Stavrakis, MD, PhD
Principal Investigator
University of Oklahoma
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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