Ear Nerve Stimulation Device Tested in Acute Heart Failure Patients
Tests a non-invasive ear nerve stimulation device in adults with sudden worsening heart failure.
Key facts
- Who runs it
- University of Oklahoma
- Where
- Oklahoma City, United StatesSee the site
- Trial code
- Registry title
- Low Level Tragus Stimulation in Acute Decompensated Heart Failure
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 16 Sept 2016
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Neuromodulation
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 admitted to hospital with acute decompensated heart failure. It tests gentle ear stimulation (tragus stimulation) against a sham treatment.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- Admitted to hospital with acute decompensated heart failure.
Main reasons for not taking part
- Complex congenital heart disease (such as Tetralogy of Fallot or single ventricle)
- Sick sinus syndrome, 2nd or 3rd degree AV block, or bifascicular block or prolonged 1st degree AV block (PR>300ms)
- Recurrent vaso-vagal fainting episodes, or vagotomy on one or both sides
- End stage renal disease on dialysis, or acute myocardial infarction
- Pregnant patients, prisoners, or refusal to consent
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Patients admitted with ADHF
Who cannot take part
- Complex congenital heart disease (Tetralogy of Fallot patients, single ventricle physiology)
- Sick sinus syndrome
- End stage renal disease on dialysis
- Acute Myocardial infarction
- Refusal to consent
- Recurrent vaso-vagal syncopal episodes
- Unilateral or bilateral vagotomy
- 2nd or 3rd degree AV block
- bifascicular block or prolonged 1st degree AV block (PR>300ms)
- Pregnant patients
- Prisoners
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- OUHSCOklahoma City, United StatesContact: Tarun DasariTaking people
About the trial
What the trial wants to find out
Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is associated with increased systemic inflammation. Previous studies have demonstrated increased levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in patients with heart failure (HF). Increased activity of sympathetic nervous system in ADHF is linked to inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated no significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS) is a non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve stimulation is thought to increase the parasympathetic activity and suppress the sympathetic activity. Clinical studies of vagal stimulation in chronic HF have been negative. Recent experimental and clinical data suggest that low level tragus nerve stimulation (LLTNS) may produce the same desired neuromodulator effect compared to LLVNS. It is however unknown if LLTNS in ADHF will directly lead to a reduction in the levels of pro-inflammatory cytokines (CRP, IL-1, IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker IL-10. heart rate variability may also be abnormal in ADHF. The objective of this proposal is to determine the impact of LLTS on inflammatory cytokines, heart failure biomarkers(Pro BNP) and HRV in patients with ADHF.In addition we will study the impact on dyspnea resolution and change in renal function during hospitalization.
Read full original descriptionShow less
Patients will be randomized to either active or sham stimulation (2 hours daily). Serum collected will (post-admission and discharge day) will be used for cytokine measurement. We will also measure daily ECG to assess HRV and patient assessed dyspnea scale.This investigation will likely establish the first evidence of the effects of LLTS on the suppression of inflammation and improvement in dyspnea, natriuretic peptides, renal function and HRV in patients presenting with ADHF.
The 2 groups in the trial
- Tragus StimulationTreatment being tested
In this group patients will receive neuromodulation for 2 hours daily
Treatment: Neuromodulation
- Control groupNo study treatment, for comparison
Sham neuromodulation will be done
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Low Level Transcutaneous Tragus Stimulation to Reduce Inflammation, Dyspnea and Improve Heart Rate Variability in Acute Decompensated Heart Failure
- Plain-language title
- Ear Nerve Stimulation Device Tested in Acute Heart Failure PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT02898181, who can take part
- Publications
- Noninvasive low-level tragus stimulation attenuates inflammation and oxidative stress in acute heart failure.Clinical autonomic research : official journal of the Clinical Autonomic Research Society, 2023
- Noninvasive low-level tragus stimulation attenuates inflammation and oxidative stress in acute heart failure.Research square, 2023
- Record updated
- 13 October 2026