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NCT Number: NCT06927024

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) 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.

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Key information

Conditions

Chronic Kidney Diseases 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Qandeel Soomro, MD

CONTACT

[email protected]

212-263-7300

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Active taVNS

Device

Active taVNS delivered via the TENS Device 7000.

Sham taVNS

Device

Sham taVNS delivered via the TENS Device 7000.

Primary outcomes

  1. 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.

  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

  3. 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.

  4. 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.

  5. Incidence of Syncope following taVNS Use

    Time frame: Up to Week 2

    Measure of safety.

Secondary outcomes

  1. 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.

  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.

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

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 15, 2025
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.

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