Transcutaneous Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease Autonomic Dysfunction

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age ≥18 years at time of informed consent
2. Documented Chronic Kidney Disease (CKD) stage G3-G5 (estimated Glomerular Filtration Rate (eGFR) 15-59 mL/min/1.73 m²), not on maintenance dialysis, based on eGFR or clinical documentation
3. Patients at New York University (NYU) clinics who meet criteria
4. Non NYU patients reaching out study team via iConnect
5. Clinically stable: No hospitalization, acute kidney injury, or acute illness requiring medical intervention within prior 4 weeks
6. Stable dosing of autonomically active medications: participants taking beta-blockers, other rate-controlling agents, anticholinergics, or sympathomimetics must be on a stable dose for ≥4 weeks before baseline with no anticipated changes during the study. Use of these agents is recorded and included as a covariate in analyses of heart-rate-based endpoints. Autonomically active medications: agents that materially affect heart rate, blood pressure, or autonomic tone - beta-blockers, non-dihydropyridine calcium-channel blockers, alpha-blockers, central sympatholytics (e.g., clonidine), midodrine, fludrocortisone, anticholinergics, sympathomimetics/stimulants, serotonin-norepinephrine reuptake inhibitors (SNRIs)/selective serotonin reuptake inhibitors (SSRIs), and diuretics are recorded with agent, dose, and timing, must be stable for ≥4 weeks before baseline with no anticipated change during the study, and are included as covariates. Home measurements are taken at a consistent time relative to the participant's usual dosing.

Exclusion Criteria:

1. Implantable cardioverter-defibrillator (ICD) or other implanted cardiac device
2. Known severe coronary disease (≥70% stenosis in major vessel) or myocardial infarction within past 5 years
3. Hospitalized within 4 weeks
4. Syncope or unexplained loss of consciousness within past 12 months
5. Uncontrolled arrhythmia (atrial fibrillation with resting heart rate \>110 bpm, recent runs of sustained ventricular tachycardia or supraventricular tachycardia) within 3 months.
6. Severe bradycardia (\<40 bpm at rest, symptomatic) , or second- or third-degree atrioventricular (AV) block without a functioning pacemaker
7. Neurological/Anatomical Exclusions:
8. History of vagotomy (surgical cutting of vagus nerve)
9. Trigeminal neuralgia within 1 year
10. Epilepsy or seizure disorder (unless well-controlled defined as seizure free with stable dose of medication for ≥2 years)
11. Dementia or cognitive impairment preventing informed consent or study compliance

Renal/General Medical Exclusions:
12. End-stage kidney disease (ESKD) on maintenance hemodialysis or peritoneal dialysis
13. Pregnancy or breastfeeding
14. Active malignancy (except non-melanoma skin cancer)
15. Severe hepatic disease (Child-Pugh Class C cirrhosis)
16. Immunosuppression (within 8 weeks of enrollment) or active immunosuppressive therapy

Skin/Electrode-Related Exclusions:
17. Active infection or severe lesions at tragus preventing electrode placement
18. Known allergy to gold or electrode materials
19. Implanted device at \<2 cm proximity to ear tragus (e.g., cochlear implant, cerebral shunt, invasive Vagus Nerve Stimulation (VNS))

Substance Use/Other:
20. Active substance uses disorder (within 1 year) or alcohol use \>14 drinks/week
21. Participation in another clinical trial within 30 days
22. Any condition that, in the investigator's judgment, would make participation unsafe or preclude compliance
23. Prisoners

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

NYU Langone Health

Study start

2026-11 Estimated

Primary completion

2028-01 Estimated

Study completion

2028-01 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts