RECRUITING

Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-07
Study Completion:2025-08-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05981183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Pacemaker dependent
  2. * Prisoners
  3. * Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
  4. * Not capable of informed consent
  5. * Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
  6. * ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
  7. * Recent myocardial infarction (4 weeks or less)
  8. * Maintenance dialysis
  9. * Epilepsy
  10. * Patients on labetalol (labetalol will interfere with catecholamine measurements)
  11. * Patients with diabetes
  12. * At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.

Contacts and Locations

Study Contact

David Charytan, MD
CONTACT
(646) 501-9086
David.charytan@nyulangone.org
Qandeel Soomro, MD
CONTACT
(212) 263-7300
Qandeel.soomro@nyulangone.org

Principal Investigator

David Charytan, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 11215
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • David Charytan, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-07
Study Completion Date2025-08-07

Study Record Updates

Study Start Date2023-08-07
Study Completion Date2025-08-07

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Disease