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

NYU Langone Health

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Device: Sham taVNS; Device: Active taVNS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06927024

1K23DK139462-01A1 (U.S. NIH Grant/Contract)

24-00756

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Active taVNS

Experimental group

Description:

Participants receive two weeks of 15-minute taVNS daily in the morning.

Treatment:

Device: Active taVNS

Sham taVNS

Sham Comparator group

Description:

Participants receive two weeks of 15-minute sham intervention daily in the morning.

Treatment:

Device: Sham taVNS