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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Ability to use the CamliGo device for 12-weeks

Willingness to complete study questionnaires, blood tests,& EndoPat testing at the beginning and end of study

Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation

Disqualifiers

Cognitively impaired patients

Patient with Bipolar disorder, psychosis or delusional disorder

History of substance abuse or dependence

History of suicidality

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CalmioGo + Standard of careExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Peripheral endothelial function

Measurements made at baseline will be significantly different between those randomized to CalmioGo + standard of care to those receiving only standard of care treatment

Time frame
16 weeks

Secondary outcomes

1

Physical assessments, cardiovascular disease biomarker blood tests as well resilience, joy, gratitude, mindfulness, health behavior , overall quality of life & perceived stress.

Measurements made at baseline will be significantly different between those randomized to CalmiGo + standard of care then those to just standard of care.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

CalmiGO

Collaborator