NCT06927024 · NYU Langone Health
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
What this study is about
30 patients will participate in a forward-looking randomly assigned clinical trial to test the safety, tolerability and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.
View original scientific description
30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.
Interventions
DEVICE
Active taVNS
Active taVNS delivered via the TENS Device 7000.
DEVICE
Sham taVNS
Sham taVNS delivered via the TENS Device 7000.
Primary outcome measures
Proportion of Patients who Complete 2 Weeks of Intervention
Time frame: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Proportion of Patients who Tolerate Each Full 15-Minute Session
Time frame: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Incidence of Severe Bradycardia following taVNS Use
Time frame: Up to Week 2
Severe bradycardia defined as heart rate (HR) \<50 beats per minute. Measure of safety.
Incidence of Severe Tachycardia following taVNS Use
Time frame: Up to Week 2
Severe tachycardia defined as heart rate (HR) \>100 beats per minute. Measure of safety.
Incidence of Syncope following taVNS Use
Time frame: Up to Week 2
Measure of safety.
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
- Individuals age ≥18 years
- Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 \[estimated glomerular filtration rate \≤60 mL/min/1.73m2\]
- Receiving care at NYU Nephrology outpatient practice
- Able to provide informed consent
Exclusion criteria
- Primary ANS disorders (e.g., Parkinson's disease)
- Arrhythmias
- Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
- On maintenance dialysis (HD)
- Symptomatic bradycardia
- Presence of an implantable defibrillators
- Presence of a permanent pacemaker
- Unable to consent
- Incarcerated individuals
- Pregnant individuals
Where
- New York, New York
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
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