Non-Invasive Ear Nerve Stimulation to Lower Inflammation and Improve Breathing and Heart Rate Variability in Adults With Acute Decompensated Heart Failure

What this Trial Is About

Acute Decompensated Heart Failure ADHF is a serious condition linked to increased inflammation and poor health outcomes. This research aims to study whether low-level tragus nerve stimulation LLTS, a non-invasive method to influence nerve activity, can reduce inflammation and improve heart function in patients with ADHF. The study evaluates changes in inflammatory markers, heart rate variability, kidney function, and breathing difficulty during hospitalization. Participants will be randomly assigned to receive either active LLTS or a sham inactive stimulation for 2 hours each day. The active treatment uses a device with electrodes attached to the ear to provide neuromodulation. Blood samples will be taken shortly after hospital admission and again at discharge to measure inflammatory and heart failure markers. Daily ECG recordings will assess heart rate variability, and patients will rate their breathing difficulty using a visual scale. During the hospital stay, participants will undergo regular blood tests, ECGs, and symptom assessments to monitor changes in inflammation, heart and kidney function, and breathing. The main outcomes include changes in cytokine levels, heart failure biomarkers, and heart rate variability over approximately 3 to 6 days. This study seeks to provide new evidence on the effects of LLTS in improving inflammation and symptoms in ADHF patients.

Low Level Tragus Stimulation in Acute Decompensated Heart Failure