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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation unit (TENS)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Charytan, MD; Phone Number: (646) 501-9086; Email: David.charytan@nyulangone.org
• Study Contact Backup: Name: Qandeel Soomro, MD; Phone Number: (212) 263-7300; Email: Qandeel.soomro@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention A; Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention A, the pulse width = 250 μs, and frequency = 50 Hz.	Device: Transcutaneous electrical nerve stimulation unit (TENS); The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.; Other Names: TENS Device 7000
Experimental: Intervention B; Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention B, the pulse width = 300 μs, frequency = 25 Hz.	Device: Transcutaneous electrical nerve stimulation unit (TENS); The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.; Other Names: TENS Device 7000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability (HRV) at Baseline	HRV is the variation in the time interval between heartbeats.	Day 1 (15 minutes prior to administration of intervention)
HRV at Post-Intervention	HRV is the variation in the time interval between heartbeats.	Day 1 (15 minutes Post-Intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention	The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.	Day 1 (Up to 15 Minutes Post-Intervention)
Blood Pressure at Baseline	Blood pressure measured continuously for 15 minutes prior to intervention.	Day 1 (15 minutes prior to administration of intervention)
Blood Pressure at Post-Intervention	Blood pressure measured continuously for 15 minutes post-intervention.	Day 1 (15 minutes Post-Intervention)
Spontaneous Baroreceptor Sensitivity (BRS) at Baseline	Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.	Day 1 (15 minutes prior to administration of intervention)
Spontaneous BRS at Post-Intervention	Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.	Day 1 (15 minutes Post-Intervention)
Heart Rate at Baseline		Day 1 (15 minutes prior to administration of intervention)
Heart Rate at Post-Intervention		Day 1 (15 minutes Post-Intervention)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David Charytan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): January 7, 2026
• Study Completion (Estimated): January 7, 2026

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 23-00778

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 used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• 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 provided access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• 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.: Yes