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NCT05994664 · ClinicalTrials.gov registry record · NA
Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients
A NA study of Vascular Ehlers-Danlos Syndrome, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05994664 is a NA study of Vascular Ehlers-Danlos Syndrome that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05994664, a NA study of Vascular Ehlers-Danlos Syndrome, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Control Group
- OTHER Heartmath Intervention
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2028-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05994664
The ClinicalTrials.gov registry entry for NCT05994664 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Vascular Ehlers-Danlos Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Control Group is the first listed.
NCT05994664 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05994664 about?
NCT05994664 is a clinical study titled "Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients". 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 perfo...
What is the current status of trial NCT05994664?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-04-01. Estimated completion is 2028-01-01.
What conditions does trial NCT05994664 study?
This clinical trial studies the following conditions: Vascular Ehlers-Danlos Syndrome.
What interventions are being tested in trial NCT05994664?
The interventions under investigation include: Control Group (OTHER), Heartmath Intervention (OTHER).
Who is sponsoring clinical trial NCT05994664?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05994664 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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