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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
NYU Langone Health·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chronic Kidney Disease
Drug/Device/Intervention
Transcutaneous electrical nerve stimulation unit (TENS)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
NYU Langone Health
Location
New York, United States of America
Timeline & enrollment
Phase
N/A
Start date
Aug 07, 2023
End date
Aug 07, 2025
Enrollment
20 participants
Primary outcome

Heart Rate Variability (HRV) at Baseline,HRV at Post-Intervention

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 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.

ICD-10 classifications
Chronic kidney diseaseChronic kidney disease, unspecifiedChronic kidney disease, stage 1Chronic kidney disease, stage 4Chronic kidney disease, stage 2
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05981183
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05981183 through Pure Global AI's free database. This phase not specified trial is sponsored by NYU Langone Health and is currently Recruiting. The study focuses on Chronic Kidney Disease. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.