NCT05981183 Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
| NCT ID | NCT05981183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Chronic Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-08-09 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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.
Contact & Investigator
David Charytan, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05981183 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05981183 currently recruiting?
Yes, NCT05981183 is actively recruiting participants. Contact the research team at David.charytan@nyulangone.org for enrollment information.
Where is the NCT05981183 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05981183 clinical trial?
NCT05981183 is sponsored by NYU Langone Health. The principal investigator is David Charytan, MD at NYU Langone Health. The trial plans to enroll 20 participants.
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