RECRUITING

Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

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

Vascular Ehlers-Danlos Syndrome (VEDS) is caused by pathogenic variants of the COL3A1 gene, resulting abnormal Type III collagen protein. This impacts the body's connective tissue and makes people with VEDS at high risk of spontaneous aortic and arterial rupture, pneumothorax, and hollow organ perforation across the age spectrum. Given this risk and high potential for lethality, VEDS is considered the most severe type of Ehlers-Danlos Syndrome. In addition, many patients experience chronic pain and fatigue, sleep disturbances, and mental health challenges. As is the case for many patients with chronic illness, stress, anxiety, and depression are often present over the course of the disease. Despite the antecedent, stress and anxiety trigger a sympathetic nervous system (SNS) response in the body, which, over a period of time, can have detrimental effects both physiologically and psychologically for patients. Recent studies have begun to use biofeedback techniques to teach patients non-pharmacological strategies for managing their autonomic nervous system. One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial was established to assess the effectiveness of a virtually based heart coherence program in a population with a chronic aortopathy in an effort to establish a larger, multi-provider program that also encompasses other cardiovascular populations.

Official Title

The Effects Of Heart Coherence Training On Patients With Vascular Ehlers-Danlos Syndrome (HEARTMATH)

Quick Facts

Study Start:2024-04-01
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05994664

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:12 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be diagnosed with Vascular Ehlers-Danlos Syndrome verified by a mutation of the COL3A1 gene
  2. * Ages 12-45 year at the time of enrollment
  3. * Access to a smartphone as well as an additional device with camera and microphone
  4. * Stable internet access
  5. * English speaking
  1. * Non-English speakers
  2. * Any conditions or developmental delays limiting the ability to utilize technology or follow directions.

Contacts and Locations

Study Contact

Shaine A Morris, MD, MPH
CONTACT
832-826-5692
shainem@bcm.edu
Jennifer Bogardus, PT, MPT, PhD
CONTACT
713-794-2070
jennifer.bogardus@utah.edu

Principal Investigator

Shaine A Morris, MD, MPH
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Shaine A Morris, MD, MPH, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

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 Date2024-04-01
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular
  • Mental Health
  • Heart Rate Variability

Additional Relevant MeSH Terms

  • Vascular Ehlers-Danlos Syndrome