Chronic Kidney Disease
Conditions
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.
Interventions
DEVICETranscutaneous 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure at Post-Intervention | Day 1 (15 minutes Post-Intervention) | Blood pressure measured continuously for 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. |
| 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) | — |
| Heart Rate at Post-Intervention | Day 1 (15 minutes Post-Intervention) | — |
| 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. |
| Blood Pressure at Baseline | Day 1 (15 minutes prior to administration of intervention) | Blood pressure measured continuously for 15 minutes prior to intervention. |
Countries
United States
Contacts
Primary ContactDavid Charytan, MD
Backup ContactQandeel Soomro, MD
Outcome results
None listed