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How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

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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 research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.

Official Title

How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

Quick Facts

Study Start:2024-12-15
Study Completion:2025-06-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06614933

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. between the ages of 18-80 years
  2. 2. English speaking (must be able to consent and complete the interviews in English)
  1. 1. chronic pain (average intensity \>2/10 on 0-10 scale, for longer than 3 months)
  2. 2. acute pain of intensity greater than 3/10
  3. 3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
  4. 4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
  5. 5. pregnancy
  6. 6. currently taking Buprenorphine or recently stopped taking (within 1 month)
  7. 7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
  8. 8. implants in the head or neck, cochlear implants, or pacemaker
  9. 9. head or neck metastasis or recent ear trauma
  10. 10. history of epilepsy
  11. 11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).

Contacts and Locations

Principal Investigator

Marlon Wong, PT, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami, Plumer Building
Coral Gables, Florida, 33146
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Marlon Wong, PT, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2024-12-15
Study Completion Date2025-06-07

Study Record Updates

Study Start Date2024-12-15
Study Completion Date2025-06-07

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy