Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Led by NYU Langone Health · Updated on 2025-12-31
20
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
You will not qualify if you...
- Pacemaker dependent
- Prisoners
- Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
- Not capable of informed consent
- Known 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 11215
Actively Recruiting
Research Team
D
David Charytan, MD
CONTACT
Q
Qandeel Soomro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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