A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Heart Rate Variability (HRV) at Baseline
Study Overview
Brief Summary
The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
Exclusion Criteria
- •Pacemaker dependent
- •Prisoners
- •Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
- •Not capable of informed consent
- •Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
- •ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
- •Recent myocardial infarction (4 weeks or less)
- •Maintenance dialysis
- •Patients on labetalol (labetalol will interfere with catecholamine measurements)
- •Patients with diabetes
- •At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.
Outcomes
Primary Outcomes
Heart Rate Variability (HRV) at Baseline
Time Frame: Day 1 (15 minutes prior to administration of intervention)
HRV is the variation in the time interval between heartbeats.
HRV at Post-Intervention
Time Frame: Day 1 (15 minutes Post-Intervention)
HRV is the variation in the time interval between heartbeats.
Secondary Outcomes
- Blood Pressure at Post-Intervention(Day 1 (15 minutes Post-Intervention))
- Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention(Day 1 (Up to 15 Minutes Post-Intervention))
- Heart Rate at Baseline(Day 1 (15 minutes prior to administration of intervention))
- Blood Pressure at Baseline(Day 1 (15 minutes prior to administration of intervention))
- Heart Rate at Post-Intervention(Day 1 (15 minutes Post-Intervention))
- Spontaneous Baroreceptor Sensitivity (BRS) at Baseline(Day 1 (15 minutes prior to administration of intervention))
- Spontaneous BRS at Post-Intervention(Day 1 (15 minutes Post-Intervention))