A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Proportion of Patients who Complete 2 Weeks of Intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
- •Symptomatic bradycardia
- •Presence of an implantable defibrillators
- •Presence of a permanent pacemaker
- •Unable to consent
- •Incarcerated individuals
- •Pregnant individuals
Arms & Interventions
Active taVNS
Participants receive two weeks of 15-minute taVNS daily in the morning.
Intervention: Active taVNS (Device)
Sham taVNS
Participants receive two weeks of 15-minute sham intervention daily in the morning.
Intervention: Sham taVNS (Device)
Outcomes
Primary Outcomes
Proportion of Patients who Complete 2 Weeks of Intervention
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to Week 2
Severe tachycardia defined as heart rate (HR) \>100 beats per minute. Measure of safety.
Incidence of Syncope following taVNS Use
Time Frame: Up to Week 2
Measure of safety.
Secondary Outcomes
- Proportion of eligible patients who consent to use the device for 2 weeks(Up to Week 2)
- Change in High Frequency (HF) Signal from Baseline(Baseline, Week 2)