Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease
• Interventions: Device: Transcutaneous electrical nerve stimulation unit (TENS)

• Registration Number: NCT05981183
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Study Start: 2023-08-07
• Study First Posted: 2023-08-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-08-07
• Study Completion: 2025-08-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.

Exclusion Criteria

• Pacemaker dependent
• Prisoners
• Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
• Not capable of informed consent
• Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
• ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
• Recent myocardial infarction (4 weeks or less)
• Maintenance dialysis
• Epilepsy
• Patients on labetalol (labetalol will interfere with catecholamine measurements)
• Patients with diabetes
• At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention A	Transcutaneous electrical nerve stimulation unit (TENS)	Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention A, the pulse width = 250 μs, and frequency = 50 Hz.
Intervention B	Transcutaneous electrical nerve stimulation unit (TENS)	Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention B, the pulse width = 300 μs, frequency = 25 Hz.

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability (HRV) at Baseline	Day 1 (15 minutes prior to administration of intervention)	HRV is the variation in the time interval between heartbeats.
HRV at Post-Intervention	Day 1 (15 minutes Post-Intervention)	HRV is the variation in the time interval between heartbeats.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure at Post-Intervention	Day 1 (15 minutes Post-Intervention)	Blood pressure measured continuously for 15 minutes post-intervention.
Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention	Day 1 (Up to 15 Minutes Post-Intervention)	The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.
Heart Rate at Baseline	Day 1 (15 minutes prior to administration of intervention)
Blood Pressure at Baseline	Day 1 (15 minutes prior to administration of intervention)	Blood pressure measured continuously for 15 minutes prior to intervention.
Heart Rate at Post-Intervention	Day 1 (15 minutes Post-Intervention)
Spontaneous Baroreceptor Sensitivity (BRS) at Baseline	Day 1 (15 minutes prior to administration of intervention)	Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Spontaneous BRS at Post-Intervention	Day 1 (15 minutes Post-Intervention)	Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States