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New treatment option for Chronic Kidney Disease
Official title Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
ClinicalTrials.gov ID: NCT05981183
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Individual 18-80 years of age with CKD stage 3-5 (eGFR \<60 mL/min/1.73m2) on most recent outpatient labs.
You likely can't join if
- 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)
See the full eligibility criteria
- Individual 18-80 years of age with CKD stage 3-5 (eGFR \<60 mL/min/1.73m2) on most recent outpatient labs.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.