Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)

December 29, 2025 updated by: NYU Langone Health

A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)

30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals age ≥18 years
  • Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 [estimated glomerular filtration rate ≤60 mL/min/1.73m2]
  • Receiving care at NYU Nephrology outpatient practice
  • Able to provide informed consent

Exclusion Criteria:

  • Primary ANS disorders (e.g., Parkinson's disease)
  • Arrhythmias
  • Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
  • On maintenance dialysis (HD)
  • Epilepsy
  • Symptomatic bradycardia
  • Presence of an implantable defibrillators
  • Presence of a permanent pacemaker
  • Unable to consent
  • Incarcerated individuals
  • Pregnant individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active taVNS
Participants receive two weeks of 15-minute taVNS daily in the morning.
Device: Active taVNS
Active taVNS delivered via the TENS Device 7000.
Sham Comparator: Sham taVNS
Participants receive two weeks of 15-minute sham intervention daily in the morning.
Device: Sham taVNS
Sham taVNS delivered via the TENS Device 7000.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients who Complete 2 Weeks of Intervention
Time Frame: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Week 2
Proportion of Patients who Tolerate Each Full 15-Minute Session
Time Frame: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Week 2
Incidence of Severe Bradycardia following taVNS Use
Time Frame: Up to Week 2
Severe bradycardia defined as heart rate (HR) <50 beats per minute. Measure of safety.
Up to Week 2
Incidence of Severe Tachycardia following taVNS Use
Time Frame: Up to Week 2
Severe tachycardia defined as heart rate (HR) >100 beats per minute. Measure of safety.
Up to Week 2
Incidence of Syncope following taVNS Use
Time Frame: Up to Week 2
Measure of safety.
Up to Week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible patients who consent to use the device for 2 weeks
Time Frame: Up to Week 2
Also known as "recruitment yield." Measure of feasibility.
Up to Week 2
Change in High Frequency (HF) Signal from Baseline
Time Frame: Baseline, Week 2
HF defined as vagal heart rate variation (HRV) modulation. Measure of efficacy.
Baseline, Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Qandeel Soomro, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-00756
  • 1K23DK139462-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Qandeel.Soomro@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Qandeel.Soomro@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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