NCT05981183 · NYU Langone Health
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Transcutaneous 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.
Primary outcome measures
Heart Rate Variability (HRV) at Baseline
Time frame: Day 1 (15 minutes prior to administration of intervention)
HRV is the variation in the time interval between heartbeats.
HRV at Post-Intervention
Time frame: Day 1 (15 minutes Post-Intervention)
HRV is the variation in the time interval between heartbeats.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 31, 2025 · Source of record for eligibility and locations