RECRUITING

Non-invasive Vagus Nerve Stimulation (nVNS) and Cognition in Young Adult Vapers - A Pilot Study

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 study is to assess the effects of non-invasive vagus nerve stimulation (nNVS) on cognitive functioning in the users of e-cigarettes or vaping products. The investigators will use a digital wellness companion product (TRUVAGA™ device) that provides mild transcutaneous nVNS. The participants will be randomized to receive either a 2-min nNVS stimulation or control stimulation in the neck region followed by completion of three cognitive tests of attention and executive function.

Official Title

Vaping and Vagal Neuromodulation of Cognition

Quick Facts

Study Start:2025-03-18
Study Completion:2028-02-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804109

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 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy young adults
  2. * Age range 18-25 years
  3. * Current or prior users of e-cigarettes
  1. * Have any rash, infection, swelling, cut, soreness, drug patch, surgical scar on the neck area
  2. * Have any implantable medical device in their body such as a pacemaker, hearing aid implant, or any other metallic/electronic device
  3. * Have any hearing or vision problems that are not corrected
  4. * Are pregnant or breastfeeding
  5. * Have any learning disabilities
  6. * Have a medical history of any of the following condition
  7. * Meningitis
  8. * Traumatic brain injury
  9. * Seizure
  10. * Syncope
  11. * Schizophrenia
  12. * Schizoaffective disorder
  13. * Bulimia (eating disorder)
  14. * Other serious neurological illness
  15. * Have a medical history of any of the following cardiac disorder
  16. * Carotid atherosclerosis or carotid artery disease
  17. * Cervical vagotomy
  18. * First degree atrioventricular block or prolonged QT interval
  19. * Are taking any medications for to treat hypertension, arrhythmias, or are on calcium channel blockers

Contacts and Locations

Study Contact

Vinay Parikh, PhD
CONTACT
215-204-1572
vinay.parikh@temple.edu

Principal Investigator

Vinay Parikh, PhD
PRINCIPAL_INVESTIGATOR
Temple University
Jason Chein, PhD
PRINCIPAL_INVESTIGATOR
Temple University
Tania Giovannetti, PhD
PRINCIPAL_INVESTIGATOR
Temple University

Study Locations (Sites)

Temple University
Philadelphia, Pennsylvania, 19122
United States

Collaborators and Investigators

Sponsor: Temple University

  • Vinay Parikh, PhD, PRINCIPAL_INVESTIGATOR, Temple University
  • Jason Chein, PhD, PRINCIPAL_INVESTIGATOR, Temple University
  • Tania Giovannetti, PhD, PRINCIPAL_INVESTIGATOR, Temple University

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 Date2025-03-18
Study Completion Date2028-02-09

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2028-02-09

Terms related to this study

Keywords Provided by Researchers

  • vaping
  • attention
  • non-invasive vagus nerve stimulation

Additional Relevant MeSH Terms

  • Vaping