Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Recruiting now · Not applicable
Conditions studied: Chronic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT05981183
- Run by
- NYU Langone Health
- People needed
- 20
- Starts
- 2023-08-09
- Expected to finish
- 2026-01-07
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
You may not qualify if…
- 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.
Where it is running
- NYU Langone Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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