No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for adults with chronic kidney disease (CKD) to test a new device. Participation involves using a nerve stimulation device to see how well it works and if it’s safe.
Are You a Good Fit for This Trial?
Must not be takingLabetalol
Rules you outAutonomic function disorder
You may be able to join if
I am between 18 and 80 years old
I have chronic kidney disease stage 3-5
My kidney function test shows an eGFR less than 60
I am able to give informed consent
You may not be able to join if
I use a pacemaker
I am a prisoner
I am pregnant or think I might be pregnant
I have Parkinson's disease with problems controlling my autonomic functions
I have had a heart attack in the past 4 weeks
I am on maintenance dialysis
I have epilepsy
I have diabetes
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 f…
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.
Trial Locations
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Eligibility Criteria
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 o…
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.
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