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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Active taVNS delivered via the TENS Device 7000.
Sham taVNS delivered via the TENS Device 7000.
NYU Langone Health
New York, New York, United States
RECRUITINGProportion 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
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