Home › Chronic Kidney Disease › NCT05981183

Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

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

Who can join

Ages 18 to 80 · All sexes

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.

About the study

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.

What is being tested

• Transcutaneous electrical nerve stimulation unit (TENS) (device)

Sponsor: NYU Langone Health · Participants: 20 · Started: Aug 9, 2023

Contact the study team

• David Charytan, MD · Phone: (646) 501-9086
• Qandeel Soomro, MD · Phone: (212) 263-7300

Official record on ClinicalTrials.gov — NCT05981183

Locations in the U.S.

Conditions

• Chronic Kidney Disease

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.