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

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT06927024
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Study Start: 2025-05-01
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Patients who Complete 2 Weeks of Intervention	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	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	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	Up to Week 2	Severe tachycardia defined as heart rate (HR) \>100 beats per minute. Measure of safety.
Incidence of Syncope following taVNS Use	Up to Week 2	Measure of safety.

Secondary Outcome Measures

Name	Time	Method
Proportion of eligible patients who consent to use the device for 2 weeks	Up to Week 2	Also known as "recruitment yield." Measure of feasibility.
Change in High Frequency (HF) Signal from Baseline	Baseline, Week 2	HF defined as vagal heart rate variation (HRV) modulation. Measure of efficacy.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States