NYU Langone Health
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 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-blocker…
The device consists of a handheld stimulation unit (\~2 inches) connected to a tragus earpiece electrode (worn like an in-ear headphone, removed after each session). Participants will undergo AVNT™ at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm at a pulse width of 250 μs, frequency of 20 Hz, and comfortable, patient-titrated intensity based on personalized perceptual thresholds.
The device is equipped with a "ramp-down sham mode". In this mode, no electrical stimulation will occur for the remainder of the session and participant intensity adjustments are disabled. Participants will use the sham-device at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm.
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