- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05994664
Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients
The Effects Of Heart Coherence Training On Patients With Vascular Ehlers-Danlos Syndrome (HEARTMATH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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. For patients with already compromised cardiovascular systems, the dysregulation of their nervous system can potentially be detrimental to their mental and physiological health, as well as their overall quality of life.
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.
Our primary aim of this study is to evaluate the effects of an 8 week, virtually-based heart coherence training program (HCTP) with the use of wearable, biofeedback technology. The goal is to perform a randomized-controlled pilot study to assess effect estimates on multiple outcomes in an effort to establish a foundation for a larger, longitudinal trial.
The objective is to:
- Randomize 20 patients with Vascular Ehlers-Danlos Syndrome from ages 12 -45 years to current status and care (controls) versus a biofeedback intervention of additional training and advancement on HeartMath techniques, then
- Allow the control group subjects to then have access to materials related to the techniques that were taught to the HMI group to allow for therapeutic equality. The investigators will then compare outcomes between both the intervention and control groups, and between the baseline and post-intervention states. Specific outcome measures will include ambulatory blood pressure, heart rate variability, coherence ratio, mean heart rate, quality of life/mental health assessment: health-related quality of life, depression and anxiety screening scales.
Our hypothesis is that individuals with VEDS undergoing a supervised HCTP will demonstrate improvements in ambulatory blood pressure, heart rate variability, and mental health survey measures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shaine A Morris, MD, MPH
- Phone Number: 832-826-5692
- Email: shainem@bcm.edu
Study Contact Backup
- Name: Jennifer Bogardus, PT, MPT, PhD
- Phone Number: 713-794-2070
- Email: jennifer.bogardus@utah.edu
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Group of up to 20 patients will be randomly allocated into an experimental group at a 1:1 ratio intervention to controls.
The experimental group will receive all of the preliminary outcome screening with the additional 10-15 minutes of training and advancement on HeartMath techniques as well as continued written and video reinforcement.
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The participants will all complete baseline surveys and paperwork including signed consent, psychometric surveys, demographic survey, and a brief, open-ended questionnaire about their feelings about living with VEDS.
During the initial visit for the intervention group the same assessment will be included, however, they will also receive 10-15 of instruction on a basic Heartmath technique.
Group participants will be asked to complete 5-10 minutes of HeartMath techniques 2x daily.
Participants from both groups will have weekly virtual sessions that include the 3-step Protocol HRV assessment.
However, each week the intervention group will receive an addition 10-15 minutes of training and advancement on HeartMath techniques as well as continued written and video reinforcement.
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Placebo Comparator: Control
Group of up to 20 patients will be randomly allocated into a control group at a 1:1 ratio for intervention to controls.
The control group will receive all of the preliminary outcome screening and will have weekly virtual sessions that include the 3-step Protocol HRV assessment.
After the CG has completed 8 weeks, they will then have access to materials related to the techniques that were taught to the HMI group to allow for therapeutic equality.
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The participants will all complete baseline surveys and paperwork including signed consent, psychometric surveys, demographic survey, and a brief, open-ended questionnaire about their feelings about living with VEDS.
The initial visit will include an HRV assessment using the HeartMath sensor via the 3-step Protocol developed by the HeartMath Institute.
Participants from both groups will have weekly virtual sessions that include the 3-step Protocol HRV assessment.
After the CG has completed 8 weeks, they will then have access to materials related to the techniques that were taught to the HMI group to allow for therapeutic equality.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Mean Overall Systolic Blood Pressure
Time Frame: 3 Months
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Comparing baseline to post-intervention overall systolic blood pressure in percent
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3 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean systolic blood pressure
Time Frame: 3 Month
|
mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
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3 Month
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Mean Diastolic blood pressure
Time Frame: 3 Month
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mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
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3 Month
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Nocturnal systolic blood pressure
Time Frame: 3 Month
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mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, nocturnal reading
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3 Month
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Nocturnal Diastolic blood pressure
Time Frame: 3 Month
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mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, nocturnal reading
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3 Month
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Diurnal Systolic blood pressure
Time Frame: 3 Month
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mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, diurnal reading
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3 Month
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Diurnal Diastolic blood pressure
Time Frame: 3 Month
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mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile, diurnal reading
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3 Month
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Daily Systolic blood pressure
Time Frame: 3 Month
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mmHg, range 70-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
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3 Month
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Daily Diastolic blood pressure
Time Frame: 3 Month
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mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile
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3 Month
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Coherence Percentage
Time Frame: 3 Months
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Between 0.04-0.24
Hz (3-15 cycles per min), The more stable and regular the heart rhythm frequency is the higher the coherence.
Percent ranges from 0.5 Basic good beginner level, 1.0 Good, 2.0 Very Good, 3.0+ Excellent.
The higher the percentage the better.
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3 Months
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Heart rate variability
Time Frame: 3 Months
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Consists of beat to beat changes in heart rate measured by values below 50 ms are classified as unhealthy, 50-100 ms have compromised health, and above 100 ms are classified as healthy.
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3 Months
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Mean Heart Rate
Time Frame: Measured at baseline and follow up visit (at 12 weeks)
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Measured for 24 hrs, range of 60-100 bpm
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Measured at baseline and follow up visit (at 12 weeks)
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Nocturnal Heart Rate
Time Frame: Measured at baseline and follow up visit (at 12 weeks)
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Adolescent: 50-90 bpm and Adult: 40-50 bpm, measured for 24 hours
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Measured at baseline and follow up visit (at 12 weeks)
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Diurnal Heart Rate
Time Frame: Measured at baseline and follow up visit (at 12 weeks)
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Adolescent: 60-100 bmp and Adult: 60-100 bmp, measured for 24 hours
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Measured at baseline and follow up visit (at 12 weeks)
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Quality of Life Scale (QOLS) (ages 19-21 y)
Time Frame: 3 Months
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16 items, each with 7 point Likert, higher is worse
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3 Months
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Pediatric Quality of Life Scale (PedsQL) scale scores
Time Frame: 3 Months
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reported in 3 domains, each reported on Likert scale, scaled to 0-100 scale, lower is worse
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3 Months
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GAD-7
Time Frame: 3 Months
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Seven-item questionnaire that detects generalized anxiety disorder and the severity of the anxiety.
Total score for the seven items ranges from 0 to 21.
The higher the score the worse; cut off score is 8.
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3 Months
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PSC
Time Frame: 3 Months
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The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children.
A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health.
PSC-35-Youth, English & Spanish cut off score is, 30 or higher.
In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.
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3 Months
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PSC-Y
Time Frame: 3 Months
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The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children.
A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health.
PSC-35-Youth, English & Spanish cut off score is, 30 or higher.
In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive.PSC Subscales:Attention Problems, Internalizing Problems, Externalizing Problems
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3 Months
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PSC-Y Attention Subscale
Time Frame: 3 Months
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The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales:Attention Problems Subscale: Children with subscores greater than or equal to 7 usually have significant impairments in attention. |
3 Months
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PSC-Y Internalizing Problems Subscale
Time Frame: 3 Months
|
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales: Internalizing Problems Subscale: Children with subscores greater than or equal to 5 usually have significant impairments with anxiety or depression. |
3 Months
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PSC-Y Externalizing Problems Subscale
Time Frame: 3 Months
|
The Pediatric Symptom Checklist (PSC) is a 35 item questionnaire that helps identify and assess changes in emotional and behavioral problems in children. A positive score on the PSC or Y-PSC suggests the need for further evaluation by a qualified health. PSC-35-Youth, English & Spanish cut off score is, 30 or higher. In a Mexican-American sample, a cutoff score of 12 was shown to be most sensitive. PSC Subscales: Externalizing Problems Subscale: Children with subscores greater than or equal to 7 usually have significant problems with conduct. |
3 Months
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PROMIS Pediatric Self- Reported Psychological Stress
Time Frame: 3 Months
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PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population.
On the T-score metric, A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
Better health is a lower score and worse health scores higher.
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3 Months
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PROMIS Parent Proxy Reported Psychological Stress- Parent Proxy
Time Frame: 3 Months
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PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population.
On the T-score metric, A score of 40 is one SD lower than the mean of the reference population.
A score of 60 is one SD higher than the mean of the reference population.
Higher score is worse health.
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3 Months
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The PROMIS Adult Depression SF v1.0 8a
Time Frame: 3 Months
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Adult measure is the 8-item PROMIS Depression Short Form v1.0 8a questionnaire that assesses the pure domain of depression in individuals age 18 and older. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average. |
3 Months
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The PROMIS Pediatric Depression SF V2.0 8a
Time Frame: 3 Months
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The PROMIS Short Form v2.0 - Depression 8a questionnaire includes 8 questions related to depressed mood in the past 7 days for ages 8-17. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average. |
3 Months
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The PROMIS Parent Proxy Depression SF v2.0 6a
Time Frame: 3 Months
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The PROMIS Short Form v2.0 - Depression 6a questionnaire includes 6 questions related to depressed mood in the past 7 days for parents serving as proxy reporters for their child (youth ages 5-17). A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like depression, a T-score of 60 is one SD worse than average. By comparison, a depression T-score of 40 is one SD better than average. |
3 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shaine A Morris, MD, MPH, Baylor college of medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Hemostatic Disorders
- Skin Diseases, Genetic
- Skin Abnormalities
- Aneurysm
- Collagen Diseases
- Dissection, Blood Vessel
- Aortic Dissection
- Syndrome
- Ehlers-Danlos Syndrome
- Ehlers-Danlos Syndrome, Type IV
Other Study ID Numbers
- H-53424
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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