Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Chronic Kidney Disease Clinical Trial

Official title:

A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981183
• Other study ID #: 23-00778
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: August 7, 2025

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: David Charytan, MD
• Phone: (646) 501-9086
• Email: David.charytan[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 7, 2025
• Est. primary completion date: August 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Transcutaneous electrical nerve stimulation unit (TENS)
The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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