Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Launched by NYU LANGONE HEALTH · Aug 1, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new treatment method for people with chronic kidney disease (CKD) using a device that stimulates the vagus nerve through the ear, known as transcutaneous auricular vagal nerve stimulation (taVNS). The main goal is to see if this treatment is safe, well-tolerated, and effective in improving health outcomes for patients with CKD. Researchers are specifically looking at how different doses of this stimulation affect participants and whether this approach could help reduce heart-related risks in this population.
To participate, individuals must be between the ages of 18 and 80 and have CKD stages 3 to 5, which means their kidney function is significantly reduced. However, certain people are not eligible, including those with pacemakers, pregnant women, or those on dialysis. Participants can expect to receive the taVNS treatment and will be monitored for any effects it may have. This trial is still recruiting, and the information gathered will help design a larger study in the future.
Gender
ALL
Eligibility criteria
- 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.
About Nyu Langone Health
NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
David Charytan, MD
Principal Investigator
NYU Langone Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported