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)
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
December 31, 2025
April 1, 2025
3.3 years
April 8, 2025
December 29, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Proportion of Patients who Complete 2 Weeks of Intervention
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Week 2
Proportion of Patients who Tolerate Each Full 15-Minute Session
Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Week 2
Incidence of Severe Bradycardia following taVNS Use
Severe bradycardia defined as heart rate (HR) \<50 beats per minute. Measure of safety.
Up to Week 2
Incidence of Severe Tachycardia following taVNS Use
Severe tachycardia defined as heart rate (HR) \>100 beats per minute. Measure of safety.
Up to Week 2
Incidence of Syncope following taVNS Use
Measure of safety.
Up to Week 2
Secondary Outcomes (2)
Proportion of eligible patients who consent to use the device for 2 weeks
Up to Week 2
Change in High Frequency (HF) Signal from Baseline
Baseline, Week 2
Study Arms (2)
Active taVNS
EXPERIMENTALParticipants receive two weeks of 15-minute taVNS daily in the morning.
Sham taVNS
SHAM COMPARATORParticipants receive two weeks of 15-minute sham intervention daily in the morning.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qandeel Soomro, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2025
First Posted
April 15, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
December 31, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Qandeel.Soomro@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Qandeel.Soomro@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.