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Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population - Trial NCT05981183

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.

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ClinicalTrials.gov โ€ข NCT05981183
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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

Study Focus

Chronic Kidney Disease

Transcutaneous electrical nerve stimulation unit (TENS)

Interventional

device

Sponsor & Location

NYU Langone Health

New York, United States of America

Timeline & Enrollment

N/A

Aug 07, 2023

Aug 07, 2025

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 disease
Chronic kidney disease, unspecified
Chronic kidney disease, stage 1
Chronic kidney disease, stage 4
Chronic kidney disease, stage 2

Data Source

ClinicalTrials.gov

NCT05981183

Device Trial