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

Trial details

Who runs it

NYU Langone Health

Trial code

NCT07927478

Record updated

2026. november 10.

Original description

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.Read full original descriptionShow less

Feasibility and Preliminary Efficacy of Transcutaneous Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease Autonomic Dysfunction: A Randomized, Sham-Controlled Pilot Trial (Parasym-CKD)

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.

Inclusion: Age ≥18 years at time of informed consent; 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; Patients at New York University (NYU) clinics who meet criteria; Non NYU patients reaching out study team via iConnect; Clinically stable: No hospitalization, acute kidney injury, or acute illness requiring medical intervention within prior 4 weeks; 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: Immunosuppression (within 8 weeks of enrollment) or active immunosuppressive therapy; Skin/Electrode-Related Exclusions:; Implanted device at <2 cm proximity to ear tragus (e.g., cochlear implant, cerebral shunt, invasive Vagus Nerve Stimulation (VNS)); Substance Use/Other:; Implantable cardioverter-defibrillator (ICD) or other implanted cardiac device; Known severe coronary disease (≥70% stenosis in major vessel) or myocardial infarction within past 5 years; Uncontrolled arrhythmia (atrial fibrillation with resting heart rate >110 bpm, recent runs of sustained ventricular tachycardia or supraventricular tachycardia) within 3 months; History of vagotomy (surgical cutting of vagus nerve); Dementia or cognitive impairment preventing informed consent or study compliance; Renal/General Medical Exclusions:; End-stage kidney disease (ESKD) on maintenance hemodialysis or peritoneal dialysis; Active malignancy (except non-melanoma skin cancer); Severe hepatic disease (Child-Pugh Class C cirrhosis); Active infection or severe lesions at tragus preventing electrode placement; Known allergy to gold or electrode materials; Active substance uses disorder (within 1 year) or alcohol use >14 drinks/week; Any condition that, in the investigator's judgment, would make participation unsafe or preclude compliance; Epilepsy or seizure disorder (unless well-controlled defined as seizure free with stable dose of medication for ≥2 years); Hospitalized within 4 weeks; Syncope or unexplained loss of consciousness within past 12 months; Severe bradycardia (<40 bpm at rest, symptomatic) , or second- or third-degree atrioventricular (AV) block without a functioning pacemaker; Neurological/Anatomical Exclusions:; Trigeminal neuralgia within 1 year; Pregnancy or breastfeeding; Participation in another clinical trial within 30 days; Prisoners.

ClinicalTrials.gov NCT07927478