A Study to Asses Wellness Using a Brain Sensing Device on Physicians

Study Overview
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Brief Summary
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A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.

Detailed Description
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Participants will be instructed on how to use a brain sensing device and corresponding digital application to engage in structured digital mindfulness practices daily for 3 months. Subjects will be requested to use the device and practice daily, but the amount of time and frequency daily will be to their choosing. Subjects will also complete questionnaires and cognitive based testing throughout participation.

Official Title
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A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing A Wearable Wellness Brain Sensing Device (Muse-S) in Practicing Physicians

Conditions
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Stress, Emotional, Sleep, Quality of Life

Intervention / Treatment
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* Device: Muse S™ Headband system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older at time of consent Practicing Physicians at Mayo Clinic Not pregnant by subject self-report at time of consent Have the ability to provide informed consent Have the ability to complete all aspects of this trial Have access to a smart phone or tablet device Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators Exclusion Criteria: Used an investigational drug within the past 30 days Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress An unstable medical or mental health condition as determined by the physician investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practicing Physicians<br>Practicing physicians at Mayo Clinic caring for patients during the COVID 19 pandemic will receive the Muse S™ Headband system, and will be asked to utilize it at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months (12 weeks). | Device: Muse S™ Headband system<br>* Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency adherence to intervention | Summarizing frequency subjects use intervention during active study participation | 3 months | 
| Duration adherence to intervention | Summarizing duration of time subjects use intervention during active study participation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, Wellness