Using a device to stimulate the vagus nerve in patients with chronic kidney disease
Official title: A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Run by NYU Langone Health · NCT05981183 · Data updated 2026-11-12
This study is testing a new device that stimulates the vagus nerve to see if it can safely help people with chronic kidney disease feel better and improve their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | August 9, 2023 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT05981183 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with chronic kidney disease stages 3-5 and an eGFR of less than 60 mL/min/1.73m2.
✕Probably not a fit
Patients with conditions such as diabetes, recent myocardial infarction, or those on certain medications like beta blockers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to gather preliminary data on the use of a transcutaneous auricular vagal nerve stimulation (taVNS) device in individuals with chronic kidney disease (CKD). It will assess the short-term safety, tolerability, and potential effects of this novel treatment approach. The study will evaluate two different doses of vagal nerve stimulation to determine feasibility and generate initial efficacy signals. The findings will inform the design of a larger study aimed at reducing cardiovascular mortality in CKD patients.
Why it matters
Potential benefit: If successful, this approach could lead to new therapeutic options that improve cardiovascular health in patients with chronic kidney disease.
How similar studies have gone: While this approach is novel in the context of CKD, similar studies using vagus nerve stimulation have shown promise in other conditions.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: David Charytan, MD — NYU Langone Health
- Study coordinator: David Charytan, MD
- Email: David.charytan@nyulangone.org
- Phone: (646) 501-9086
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.