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

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

Treatments tested in this trial

  • CalmioGO Stress management device

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

CalmiGO

Collaborator