Non-invasive stimulation of the tragus to reduce inflammation in heart failure patients
Low Level Transcutaneous Tragus Stimulation to Reduce Inflammation, Dyspnea and Improve Heart Rate Variability in Acute Decompensated Heart Failure
This study is testing if a new way of stimulating a small nerve in the ear can help reduce inflammation and improve heart function in patients with severe heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT02898181 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-level tragus nerve stimulation (LLTS) on patients with acute decompensated heart failure (ADHF), a condition characterized by increased systemic inflammation and poor outcomes. Patients will be randomized to receive either active or sham stimulation for two hours daily, with the aim of assessing changes in inflammatory cytokines and heart rate variability. The study seeks to determine whether LLTS can effectively modulate autonomic tone and reduce inflammation in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients admitted with acute decompensated heart failure.
Not a fit: Patients with complex congenital heart disease, advanced renal dysfunction, or those with certain heart block conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option to reduce inflammation and improve outcomes in patients with acute decompensated heart failure.
How similar studies have performed: While previous studies on vagal nerve stimulation in chronic heart failure have shown negative results, the approach of low-level tragus nerve stimulation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients admitted with ADHF Exclusion Criteria: 1. Refusal to consent 2. Complex congenital heart disease (Tetralogy of Fallot patients, single ventricle physiology) 3. Recurrent vaso-vagal syncopal episodes 4. Unilateral or bilateral vagotomy 5. Sick sinus syndrome 6. 2nd or 3rd degree AV block 7. bifascicular block or prolonged 1st degree AV block (PR\>300ms) 8. Pregnant patients 9. Prisoners 10. Advanced renal dysfunction(defined as eGFR \< 30, stage 4 or 5 chronic kidney disease) 11. Hepatitis C or HIV 12. Acute Myocardial infarction
Where this trial is running
Oklahoma City, Oklahoma
- Ouhsc — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Tarun Dasari, MD,MPH — Ouhsc
- Study coordinator: Tarun Dasari, MD,MPH
- Email: tdasari@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.