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

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

No aplica

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

30 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

Asignación al azar

Enmascaramiento

Enmascaramiento doble

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Equipo y fechas

Patrocinador principal

NYU Langone Health

Inicio del estudio

2026-11 Estimado

Finalización primaria

2028-01 Estimado

Finalización del estudio

2028-01 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio