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Recruiting NCT05981183

Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

No phase Interventional Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous electrical nerve stimulation unit (TENS).
Who it may be relevant to
Registry conditions: Chronic Kidney Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Overview

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.

Interventions

  • Device Transcutaneous electrical nerve stimulation unit (TENS)
    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.

Primary outcome measures

  • Heart Rate Variability (HRV) at Baseline [Time frame: Day 1 (15 minutes prior to administration of intervention)]
  • HRV at Post-Intervention [Time frame: Day 1 (15 minutes Post-Intervention)]
Secondary outcome measures (7)
  • Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention [Time frame: Day 1 (Up to 15 Minutes Post-Intervention)]
  • Blood Pressure at Baseline [Time frame: Day 1 (15 minutes prior to administration of intervention)]
  • Blood Pressure at Post-Intervention [Time frame: Day 1 (15 minutes Post-Intervention)]
  • Spontaneous Baroreceptor Sensitivity (BRS) at Baseline [Time frame: Day 1 (15 minutes prior to administration of intervention)]
  • Spontaneous BRS at Post-Intervention [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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05981183 · 23-00778

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗