RecruitingNot ApplicableNCT06927024

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)

A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)


Sponsor

NYU Langone Health

Enrollment

30 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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)
  • Epilepsy
  • Symptomatic bradycardia
  • Presence of an implantable defibrillators
  • Presence of a permanent pacemaker
  • Unable to consent
  • Incarcerated individuals
  • Pregnant individuals

Interventions

DEVICEActive taVNS

Active taVNS delivered via the TENS Device 7000.

DEVICESham taVNS

Sham taVNS delivered via the TENS Device 7000.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT06927024


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