Clinical trial NCT05981183: Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Official title: A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* Epilepsy
* 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.

Primary outcomes:
measure: Heart Rate Variability (HRV) at Baseline
timeFrame: Day 1 (15 minutes prior to administration of intervention)
measure: HRV at Post-Intervention
timeFrame: Day 1 (15 minutes Post-Intervention)
Secondary outcomes:
measure: Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention
timeFrame: Day 1 (Up to 15 Minutes Post-Intervention)
measure: Blood Pressure at Baseline
timeFrame: Day 1 (15 minutes prior to administration of intervention)
measure: Blood Pressure at Post-Intervention
timeFrame: Day 1 (15 minutes Post-Intervention)
measure: Spontaneous Baroreceptor Sensitivity (BRS) at Baseline
timeFrame: Day 1 (15 minutes prior to administration of intervention)
measure: Spontaneous BRS at Post-Intervention
timeFrame: Day 1 (15 minutes Post-Intervention)
measure: Heart Rate at Baseline
timeFrame: Day 1 (15 minutes prior to administration of intervention)
measure: Heart Rate at Post-Intervention
timeFrame: Day 1 (15 minutes Post-Intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Charytan, MD
role: PRINCIPAL_INVESTIGATOR
References: