RecruitingNot ApplicableNCT05981183

Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Sponsor

NYU Langone Health

Enrollment

20 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease

Summary

The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small wearable device that stimulates a nerve in the ear (the vagus nerve) through the skin to see if it can help people with chronic kidney disease (CKD) by regulating the nervous system. **You may be eligible if:** - You are 18–80 years old - You have chronic kidney disease stage 3–5 (meaning your kidneys are functioning at less than 60% of normal) - You are not currently on dialysis - You do not have diabetes - You do not have a pacemaker or defibrillator **You may NOT be eligible if:** - You depend on a pacemaker - You are pregnant - You have epilepsy - You have recently had a heart attack (within 4 weeks) - You are on dialysis - You have a known disorder of the autonomic nervous system (like Parkinson's with autonomic dysfunction) - You are taking the blood pressure medication labetalol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous electrical nerve stimulation unit (TENS)

The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.

Locations(1)

NYU Langone Health

New York, New York, United States

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NCT05981183

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