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Behavioural Intervention

Heart Coherence Training for Ehlers-Danlos Syndrome

N/A

Waitlist Available

Led By Shaine A Morris, MD, MPH

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 12-45 year at the time of enrollment

Participants must be diagnosed with Vascular Ehlers-Danlos Syndrome verified by a mutation of the COL3A1 gene

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month

Awards & highlights

Study Summary

This trial studies a program to help people with Vascular Ehlers-Danlos Syndrome, a rare connective tissue disorder, manage the stress, anxiety, and physical symptoms that come with it.

Who is the study for?

This trial is for individuals aged 12-45 with Vascular Ehlers-Danlos Syndrome confirmed by a COL3A1 gene mutation. Participants must have access to a smartphone, another device with camera and microphone, stable internet, and be English-speaking. It excludes non-English speakers or those unable to use technology or follow instructions due to conditions or developmental delays.Check my eligibility

What is being tested?

The study tests the effectiveness of Heartmath®, a virtual heart coherence program designed to help manage stress, anxiety, and blood pressure in patients with chronic aortopathy. The goal is to see if this biofeedback technique can improve mental health without medication.See study design

What are the potential side effects?

Since Heartmath® involves non-pharmacological strategies like biofeedback for managing stress rather than drugs, it's not expected to have typical medicinal side effects. However, participants may experience frustration or fatigue from learning new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 45 years old.

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I have Vascular Ehlers-Danlos Syndrome confirmed by a COL3A1 gene mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change in Mean Overall Systolic Blood Pressure

Secondary outcome measures

Coherence Percentage

Daily Diastolic blood pressure

Daily Systolic blood pressure

+23 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 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.

Group II: ControlPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,912 Total Patients Enrolled

1 Trials studying Ehlers-Danlos Syndrome

20 Patients Enrolled for Ehlers-Danlos Syndrome

Southern Star Research Pty Ltd.Industry Sponsor

13 Previous Clinical Trials

566 Total Patients Enrolled

Shaine A Morris, MD, MPHPrincipal InvestigatorBaylor College of Medicine

2 Previous Clinical Trials

62 Total Patients Enrolled

Media Library

Heartmath Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05994664 — N/A

Ehlers-Danlos Syndrome Research Study Groups: Intervention, Control

Ehlers-Danlos Syndrome Clinical Trial 2023: Heartmath Intervention Highlights & Side Effects. Trial Name: NCT05994664 — N/A

Heartmath Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994664 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project permit the inclusion of individuals above fifty years of age?

"The parameters of this trial necessitate that applicants are between the ages of 12 and 45. Additionally, there are 377 trials for minors (under 18) and 1004 studies aiming to involve seniors (over 65)."

Answered by AI

How can I become involved in this clinical exploration?

"To be considered for participation, participants must have been medically diagnosed with Ehlers-Danlos Syndrome and fall between the ages of 12 to 45. This study is looking to enroll up to 40 individuals."

Answered by AI

Are participants being recruited for this research trial at the present time?

"Contrary to expectations, clinicaltrials.gov confirms that this medical study is no longer recruiting participants as of August 9th 2023. The trial was first posted on September 1st and has since been superseded by the 1439 other trials seeking enrollees at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients

Shaine Morris 2024. "Heart Coherence Training on Vascular Ehlers-Danlos Syndrome Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05994664.