Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05981183

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 11215, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: TENS Device 7000

Primary outcomes

  1. Heart Rate Variability (HRV) at Baseline

    Time frame: Day 1 (15 minutes prior to administration of intervention)

    HRV is the variation in the time interval between heartbeats.

  2. HRV at Post-Intervention

    Time frame: Day 1 (15 minutes Post-Intervention)

    HRV is the variation in the time interval between heartbeats.

Secondary outcomes

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

    Time frame: Day 1 (Up to 15 Minutes Post-Intervention)

    The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.

  2. Blood Pressure at Baseline

    Time frame: Day 1 (15 minutes prior to administration of intervention)

    Blood pressure measured continuously for 15 minutes prior to intervention.

  3. Blood Pressure at Post-Intervention

    Time frame: Day 1 (15 minutes Post-Intervention)

    Blood pressure measured continuously for 15 minutes post-intervention.

  4. Spontaneous Baroreceptor Sensitivity (BRS) at Baseline

    Time frame: Day 1 (15 minutes prior to administration of intervention)

    Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.

  5. Spontaneous BRS at Post-Intervention

    Time frame: Day 1 (15 minutes Post-Intervention)

    Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.

  6. Heart Rate at Baseline

    Time frame: Day 1 (15 minutes prior to administration of intervention)

  7. Heart Rate at Post-Intervention

    Time frame: Day 1 (15 minutes Post-Intervention)

Study contacts

Contact information is provided by the study sponsor or research team.

David Charytan, MD

CONTACT

[email protected]

(646) 501-9086

Qandeel Soomro, MD

CONTACT

[email protected]

(212) 263-7300

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.