An interventional study of Active taVNS and Sham taVNS in Chronic Kidney Diseases, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive two weeks of 15-minute taVNS daily in the morning.
Device: Active taVNS
Participants receive two weeks of 15-minute sham intervention daily in the morning.
Device: Sham taVNS
Active taVNS delivered via the TENS Device 7000.
Sham taVNS delivered via the TENS Device 7000.
Proportion of Patients who Complete 2 Weeks of Intervention
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Time frame: 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
Time frame: Week 2
Incidence of Severe Bradycardia following taVNS Use
Severe bradycardia defined as heart rate (HR) \<50 beats per minute. Measure of safety.
Time frame: 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.
Time frame: Up to Week 2
Incidence of Syncope following taVNS Use
Measure of safety.
Time frame: Up to Week 2
Proportion of eligible patients who consent to use the device for 2 weeks
Also known as "recruitment yield." Measure of feasibility.
Time frame: Up to Week 2
Change in High Frequency (HF) Signal from Baseline
HF defined as vagal heart rate variation (HRV) modulation. Measure of efficacy.
Time frame: Baseline, Week 2
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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