NCT05981183Recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 9 Aug 2023
- Primary completion date
- 7 Jan 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Chronic kidney disease
- NCT number
- NCT05981183
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 9 Aug 2023 to the primary completion date, 7 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- Individual 18-80 years of age with CKD stage 3-5 (eGFR \<60 mL/min/1.73m2) on most recent outpatient labs.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.