A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
NYU Langone Health
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceActive taVNS
Active taVNS delivered via the TENS Device 7000.
- DeviceSham taVNS
Sham taVNS delivered via the TENS Device 7000.
Location
- NYU Langone HealthNew York, New York