Recruiting

taVNS

Sponsor:

NYU Langone Health

Code:

NCT06927024

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active taVNS

Sham taVNS

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Diseases

Study ID

NCT06927024

Start date

Oct 15, 2025

Status verified date

Apr, 2025

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active taVNS

Participants receive two weeks of 15-minute taVNS daily in the morning.

sham comparator: Sham taVNS

Participants receive two weeks of 15-minute sham intervention daily in the morning.

Interventions

Active taVNS

Active taVNS delivered via the TENS Device 7000.

Sham taVNS

Sham taVNS delivered via the TENS Device 7000.

Primary outcome measure

  • Proportion of Patients who Complete 2 Weeks of Intervention [ Time Frame: Week 2 ]
  • Proportion of Patients who Tolerate Each Full 15-Minute Session [ Time Frame: Week 2 ]
  • Incidence of Severe Bradycardia following taVNS Use [ Time Frame: Up to Week 2 ]
  • Incidence of Severe Tachycardia following taVNS Use [ Time Frame: Up to Week 2 ]
  • Incidence of Syncope following taVNS Use [ Time Frame: Up to Week 2 ]

Central Contacts and Locations

Central contacts

Qandeel Soomro, MD

(212) 263-7300Qandeel.Soomro@nyulangone.org

David Charytan, MD

(646) 501-9086David.Charytan@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Qandeel Soomro, MD

212-263-7300Qandeel.Soomro@nyulangone.org

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 31, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-31.