Auricular Vagal Neuromodulation for Chronic Kidney Disease

QS
DM
Overseen ByDavid Moran
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this pilot study is to establish the feasibility of home-based Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease (CKD) patients, generate preliminary efficacy data on autonomic function outcomes, and explore whether timing variation influences treatment response.

Who Is on the Research Team?

QS

Qandeel Soomro, MD, MS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people with chronic kidney disease who may have problems with their body's automatic functions, like heart rate or blood pressure. Specific inclusion and exclusion criteria are not listed, but participants must have CKD.

Inclusion Criteria

Patients at New York University (NYU) clinics who meet criteria
I have stage 3 to 5 chronic kidney disease and am not on dialysis.
I am not an NYU patient and contacted the study team through iConnect.
See 3 more

Exclusion Criteria

Hospitalized within 4 weeks
Active substance use disorder within 1 year or alcohol use >14 drinks/week
I do not have an active infection or severe sores on my tragus.
See 19 more

What Are the Treatments Tested in This Trial?

Interventions

  • Auricular Vagal Neuromodulation Therapy (AVNT™)

Trial Overview

The study tests a device called Auricular Vagal Neuromodulation Therapy (AVNT™), which stimulates the ear to affect nerve activity. Some participants will use the real device at home, while others will use a sham (inactive) device for comparison.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active-PMExperimental Treatment1 Intervention
Group II: Active-AMExperimental Treatment1 Intervention
Group III: Sham-AMPlacebo Group1 Intervention
Group IV: Sham-PMPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+