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

Detailed criteria

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

Device
Active taVNS
Active taVNS delivered via the TENS Device 7000.
Device
Sham taVNS
Sham taVNS delivered via the TENS Device 7000.

Location

NYU Langone Health
New York, New York
Qandeel.Soomro@nyulangone.org 212-263-7300

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

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions