Status:
RECRUITING
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Lead Sponsor:
NYU Langone Health
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 di...
Eligibility Criteria
Inclusion
- • Individual 18-80 years of age with CKD stage 3-5 (eGFR \<60 mL/min/1.73m2) on most recent outpatient labs.
Exclusion
- 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.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 7 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05981183
Start Date
August 9 2023
End Date
January 7 2026
Last Update
December 31 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 11215