Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)

A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06927024

Enrollment

Registered

2025-04-15

Start date

2025-10-15

Completion date

2029-01-31

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Brief summary

30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.

Interventions

DEVICEActive taVNS

Active taVNS delivered via the TENS Device 7000.

DEVICESham taVNS

Sham taVNS delivered via the TENS Device 7000.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Patients who Tolerate Each Full 15-Minute Session	Week 2	Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Incidence of Severe Tachycardia following taVNS Use	Up to Week 2	Severe tachycardia defined as heart rate (HR) \>100 beats per minute. Measure of safety.
Incidence of Syncope following taVNS Use	Up to Week 2	Measure of safety.
Proportion of Patients who Complete 2 Weeks of Intervention	Week 2	Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Incidence of Severe Bradycardia following taVNS Use	Up to Week 2	Severe bradycardia defined as heart rate (HR) \<50 beats per minute. Measure of safety.

Secondary

Measure	Time frame	Description
Change in High Frequency (HF) Signal from Baseline	Baseline, Week 2	HF defined as vagal heart rate variation (HRV) modulation. Measure of efficacy.
Proportion of eligible patients who consent to use the device for 2 weeks	Up to Week 2	Also known as recruitment yield. Measure of feasibility.

Countries

United States

Contacts

Primary ContactQandeel Soomro, MD

Qandeel.Soomro@nyulangone.org(212) 263-7300

Backup ContactDavid Charytan, MD

David.Charytan@nyulangone.org(646) 501-9086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026