RECRUITING

Heart Rate Variability Biofeedback Following Traumatic Brain Injury

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

Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).

Official Title

A Randomized Controlled Trial of Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Quick Facts

Study Start:2023-02-15
Study Completion:2024-04-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05913505

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 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least six months post-injury to account for spontaneous recovery
  2. * Aged 18-55 years
  3. * Fluent in English
  4. * Able to provide informed consent.
  1. * Presence of a pacemaker
  2. * Previous self-reported heart attack with hospitalization
  3. * Diagnosed learning disability
  4. * Other neurological difficulties or diagnoses (i.e., stroke, epilepsy)
  5. * Participation in current litigation
  6. * Uncorrected visual impairment.

Contacts and Locations

Study Contact

Leah D Talbert, MS
CONTACT
3343141078
leah.d.whitlow@gmail.com
Michael J Larson, PhD
CONTACT
8014226125
michael_larson@byu.edu

Principal Investigator

Michael J Larson, PhD
STUDY_CHAIR
Brigham Young University

Study Locations (Sites)

Brigham Young University
Provo, Utah, 84606
United States

Collaborators and Investigators

Sponsor: Brigham Young University

  • Michael J Larson, PhD, STUDY_CHAIR, Brigham Young 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 Date2023-02-15
Study Completion Date2024-04-24

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2024-04-24

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury