Ear-based vagus nerve stimulation for people with stage 3–5 chronic kidney disease
Official title: A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
Run by NYU Langone Health · NCT06927024 · Data updated 2026-11-12
This trial will test whether noninvasive ear-based vagus nerve stimulation is safe, tolerable, and can improve autonomic nervous system function in adults with stage 3–5 chronic kidney disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | January 31, 2029 |
| Study ends | January 31, 2029 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06927024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with CKD stage 3–5 (eGFR ≤60 mL/min/1.73 m2) who receive care at NYU Langone's nephrology outpatient practice and can provide informed consent.
✕Probably not a fit
Patients on maintenance dialysis, with primary autonomic disorders, implantable pacemakers/ICDs, uncontrolled arrhythmias, epilepsy, pregnancy, or those unable to consent are excluded and unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized pilot trial enrolling 30 adults with CKD stages 3–5 to receive either active transcutaneous auricular vagus nerve stimulation (taVNS) or a sham device. Participants will be randomized to active or sham taVNS and monitored for safety, tolerability, and changes in autonomic function measures such as heart rate variability. The trial excludes patients on maintenance dialysis, those with implantable cardiac devices or primary autonomic disorders, and other standard safety exclusions. The study is conducted at the NYU Langone Health nephrology outpatient practice with oversight from investigators and NIDDK collaborators.
Why it matters
Potential benefit: If successful, this noninvasive approach could improve autonomic regulation and potentially reduce symptoms or cardiovascular risk linked to ANS dysfunction in CKD patients.
How similar studies have gone: Noninvasive vagus nerve stimulation has shown promise in other conditions for modulating autonomic balance and heart rate variability, but its application specifically in CKD is novel with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals age ≥18 years * Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 \[estimated glomerular filtration rate \≤60 mL/min/1.73m2\] * Receiving care at NYU Nephrology outpatient practice * Able to provide informed consent Exclusion Criteria: * Primary ANS disorders (e.g., Parkinson's disease) * Arrhythmias * Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation) * On maintenance dialysis (HD) * Epilepsy * Symptomatic bradycardia * Presence of an implantable defibrillators * Presence of a permanent pacemaker * Unable to consent * Incarcerated individuals * Pregnant individuals
Where it's running
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NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Qandeel Soomro, MD — NYU Langone Health
- Study coordinator: Qandeel Soomro, MD
- Email: Qandeel.Soomro@nyulangone.org
- Phone: (212) 263-7300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.