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Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

RecruitingNAAges 18 Years - 80 YearsAllNYU Langone Health
NCT05981183 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: • Individual 18-80 years of age with CKD stage 3-5 (eGFR \<60 mL/min/1.73m2) on most recent outpatient labs. Exclusion Criteria: * Pacemaker dependent * Prisoners * Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant. * Not capable of informed consent * Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction) * ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation) * Recent myocardial infarction (4 weeks or less) * Maintenance dialysis * Epilepsy * Patients on labetalol (labetalol will interfere with catecholamine measurements) * Patients with diabetes * At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.
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What it tests

  • Transcutaneous electrical nerve stimulation unit (TENS)
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Where

1 site
NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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