Ear-based vagus nerve stimulation for people with stage 3–5 chronic kidney disease
A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06927024 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.