Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

NCT05981183 | Recruiting FDA Device

• 1 other identifier: 23-00778
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention

  Day 1 (Up to 15 Minutes Post-Intervention)

• Blood Pressure at Baseline

  Day 1 (15 minutes prior to administration of intervention)

• Blood Pressure at Post-Intervention

  Day 1 (15 minutes Post-Intervention)

• Spontaneous Baroreceptor Sensitivity (BRS) at Baseline

  Day 1 (15 minutes prior to administration of intervention)

• Spontaneous BRS at Post-Intervention

  Day 1 (15 minutes Post-Intervention)

Study Arms (2)

Intervention A

EXPERIMENTAL

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)

Intervention B

EXPERIMENTAL

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)

Interventions

Transcutaneous electrical nerve stimulation unit (TENS) DEVICE

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.

Also known as: TENS Device 7000

Intervention A; Intervention B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 11215, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Charytan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Charytan, MD

CONTACT

(646) 501-9086; David.charytan@nyulangone.org

Qandeel Soomro, MD

CONTACT

(212) 263-7300; Qandeel.soomro@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: August 9, 2023
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)