Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04521699
Status
Recruiting
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Conditions

  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CalmioGO Stress management device — 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.

Study Details

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.

Key Dates

Start date
Jan 13, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CalmioGo + Standard of care
    Use of CalmiGO stress management device once daily + standard of care during the 12 weeks of Cardiac rehabilitation
  • No Intervention: Standard of Care
    Stand of care alone with 12 weeks of Cardiac rehabilitation

Primary Outcome Measure

Peripheral endothelial function [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Amanda Priebe
[email protected]
507-422-6932
Diana Albers
[email protected]
507-255-6884
Valentina Nardi, MD (PRINCIPAL_INVESTIGATOR)

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