The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function (LLT-SPANS)
Atrial Fibrillation, Heart Failure, Diastolic
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Male and female patients older than 21 year old
- Healthy volunteers free from diagnosis of AF, heart failure, coronary artery disease or diseases that affect the autonomic nervous system.
- Patients with Paroxysmal Atrial Fibrillation
- Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)
Exclusion Criteria:
- Recent (<6 months) stroke
- Recent (<6 months) myocardial infarction
- Heart failure (NYHA class III or IV)
- Left ventricular ejection fraction <50%
- Recurrent vaso-vagal syncopal episodes
- Unilateral or bilateral vagotomy
- Pregnancy or breast feeding
- Uncontrolled diabetes or hypertension
- Inability or unwillingness to understand and/or sign informed consent
- Any serious disease that affects autonomic nervous system function
- Any medications that affect autonomic nervous system function
Sites / Locations
- University of Oklahoma Health Sciences CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Active Comparator
Frequency 20Hz; amplitude 1mA below discomfort threshold
Frequency 5Hz; amplitude 1mA below discomfort threshold
Frequency 20Hz; amplitude 50% below discomfort threshold
Frequency 5Hz; amplitude 50% below discomfort threshold
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.