RECRUITING

Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

Conditions

Quick Navigation

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 Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system.

Official Title

Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)

Quick Facts

Study Start:2022-08-22

Study Completion:2024-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05350150

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.	* Previous EPS with ablation * Previous failed ablation * Known conduction system disease, right or left bundle branch block on EKG * Pregnant women * History of postural orthostatic tachycardia syndrome * Patients who have had prior cervical vagotomy * Patients with skin on the tragus that is broken or cracked * Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis) * Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.

Inclusion Criteria

Exclusion Criteria

* Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.

* Previous EPS with ablation
* Previous failed ablation
* Known conduction system disease, right or left bundle branch block on EKG
* Pregnant women
* History of postural orthostatic tachycardia syndrome
* Patients who have had prior cervical vagotomy
* Patients with skin on the tragus that is broken or cracked
* Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
* Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.

Contacts and Locations

Study Contact

Kristie Coleman, RN

CONTACT

2124346500

kcoleman1@northwell.edu

Principal Investigator

Stavros E Mountantonakis, MD

PRINCIPAL_INVESTIGATOR

Northwell Health

Study Locations (Sites)

Kristie Coleman

New York, New York, 10075

United States

Collaborators and Investigators

Sponsor: Northwell Health

Stavros E Mountantonakis, MD, PRINCIPAL_INVESTIGATOR, Northwell 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 Date2022-08-22

Study Completion Date2024-11-30

Study Record Updates

Study Start Date2022-08-22

Study Completion Date2024-11-30

Terms related to this study

Additional Relevant MeSH Terms

Neuromodulation