Heart Coherence Training for Patients with Vascular Ehlers-Danlos Syndrome
The Effects Of Heart Coherence Training On Patients With Vascular Ehlers-Danlos Syndrome (HEARTMATH)
NA · Baylor College of Medicine · NCT05994664
This study is testing an 8-week online program to see if heart coherence training can help people with Vascular Ehlers-Danlos Syndrome manage stress and anxiety better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 45 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05994664 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of an 8-week virtual Heartmath® intervention designed to help patients with Vascular Ehlers-Danlos Syndrome (VEDS) manage stress and anxiety through biofeedback techniques. VEDS is a severe condition caused by mutations in the COL3A1 gene, leading to significant health risks and mental health challenges. The intervention aims to improve heart rate variability and overall quality of life by teaching patients non-pharmacological strategies to regulate their autonomic nervous system. Participants will be monitored for changes in stress levels, anxiety, and physiological responses throughout the program.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12-45 diagnosed with Vascular Ehlers-Danlos Syndrome confirmed by a COL3A1 gene mutation.
Not a fit: Patients who do not speak English or have conditions that limit their ability to use technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental and physiological health of patients with VEDS, enhancing their quality of life.
How similar studies have performed: Other studies utilizing biofeedback techniques have shown promise in managing stress and anxiety, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be diagnosed with Vascular Ehlers-Danlos Syndrome verified by a mutation of the COL3A1 gene * Ages 12-45 year at the time of enrollment * Access to a smartphone as well as an additional device with camera and microphone * Stable internet access * English speaking Exclusion Criteria: * Non-English speakers * Any conditions or developmental delays limiting the ability to utilize technology or follow directions.
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Shaine A Morris, MD, MPH — Baylor College of Medicine
- Study coordinator: Shaine A Morris, MD, MPH
- Email: shainem@bcm.edu
- Phone: 832-826-5692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vascular Ehlers-Danlos Syndrome, Cardiovascular, Mental Health, Heart Rate Variability