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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.
NYU Langone Health
New York, New York, United States
RECRUITINGHeart Rate Variability (HRV) at Baseline
HRV is the variation in the time interval between heartbeats.
Time frame: Day 1 (15 minutes prior to administration of intervention)
HRV at Post-Intervention
HRV is the variation in the time interval between heartbeats.
Time frame: Day 1 (15 minutes Post-Intervention)
Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention
The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.
Time frame: Day 1 (Up to 15 Minutes Post-Intervention)
Blood Pressure at Baseline
Blood pressure measured continuously for 15 minutes prior to intervention.
Time frame: Day 1 (15 minutes prior to administration of intervention)
Blood Pressure at Post-Intervention
Blood pressure measured continuously for 15 minutes post-intervention.
Time frame: Day 1 (15 minutes Post-Intervention)
Spontaneous Baroreceptor Sensitivity (BRS) at Baseline
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Time frame: Day 1 (15 minutes prior to administration of intervention)
Spontaneous BRS at Post-Intervention
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Time frame: Day 1 (15 minutes Post-Intervention)
Heart Rate at Baseline
Time frame: Day 1 (15 minutes prior to administration of intervention)
Heart Rate at Post-Intervention
Time frame: Day 1 (15 minutes Post-Intervention)
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