Tests an ear-based nerve stimulation device in people with chronic kidney disease
Tests a device that stimulates the vagus nerve through the ear in chronic kidney disease.
Plain-language title generated from the registry record
Registry title: Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Key facts
- Where
- New York, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05981183, who can take part
Where in United States
- NYU Langone HealthNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NYU Langone Health
- Trial code
- NCT05981183
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
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.
Inclusion: Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
Exclusion: 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); Epilepsy; Patients with diabetes; Pacemaker dependent; Prisoners; Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant; Not capable of informed consent; Maintenance dialysis; Patients on labetalol (labetalol will interfere with catecholamine measurements); At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.