Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Study Details
Study Description
Brief Summary
The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
100 patients who have recently had an acute Myocardial Infarction ( heart attack) and are under going clinically indicated cardiac rehabilitation will undergo baseline testing including EndoPAT testing, mental stress testing, blood tests for cardiovascular disease biomarkers , physical assessments & survey questionnaires. Patients then will be randomized to either CalmioGO stress management device + standard of care treatment or just standard of care treatment. Those randomized to CalmiGO stress management device treatment will be instructed to use the hand device much like an inhaler once a day for 12 weeks. After 12 weeks of rehabilitation both groups will return for reassessment of baseline tests.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CalmioGo + Standard of care Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation |
Device: CalmioGO Stress management device
CalmiGo device is a device of similar size to an inhaler that uses guided breathing, and grounding techniques to regulate breathing to bring users a sense of calm and relaxation.
|
| No Intervention: Standard of Care Stand of care alone with 12 weeks of Cardiac rehabilitation |
Outcome Measures
Primary Outcome Measures
- Peripheral endothelial function [16 weeks]
Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment
Secondary Outcome Measures
- Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress. [16 weeks]
Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older
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Ability to use the CamliGo device for 12-weeks
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Willingness to complete study questionnaires, blood tests,& EndoPat testing at the beginning and end of study
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Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation
Exclusion Criteria:
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Pregnant Patient
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Cognitively impaired patients
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Patient with Bipolar disorder, psychosis or delusional disorder
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History of substance abuse or dependence
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History of suicidality
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Unstable cardiovascular or pulmonary disease
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History of seizures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- CalmiGO
Investigators
- Principal Investigator: Amir Lerman, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-005047