Recruiting

taVNS

Sponsor:

NYU Langone Health

Code:

NCT05981183

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous electrical nerve stimulation unit (TENS)

Study Details

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

Study ID

NCT05981183

Start date

Aug 9, 2023

Status verified date

Jun, 2025

Completion date

Jan 7, 2026

Anticipated

Primary completion date

Jan 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Heart Rate Variability (HRV) at Baseline [ Time Frame: Day 1 (15 minutes prior to administration of intervention) ]
  • HRV at Post-Intervention [ Time Frame: Day 1 (15 minutes Post-Intervention) ]

Central Contacts and Locations

Central contacts

David Charytan, MD

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

Qandeel Soomro, MD

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 11215

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 31, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.