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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04743973
Collaborator
InteraXon, Inc. (Industry), Cambridge Brain Sciences (Industry)
20
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Muse S™ Headband system
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing A Wearable Wellness Brain Sensing Device (Muse-S) in Practicing Physicians
Actual Study Start Date :
Aug 15, 2021
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Practicing Physicians

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
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.

Outcome Measures

Primary Outcome Measures

  1. Frequency adherence to intervention [3 months]

    Summarizing frequency subjects use intervention during active study participation

  2. Duration adherence to intervention [3 months]

    Summarizing duration of time subjects use intervention during active study participation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

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
  • InteraXon, Inc.
  • Cambridge Brain Sciences

Investigators

  • Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ivana Croghan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04743973
Other Study ID Numbers:
  • 20-007207
First Posted:
Feb 8, 2021
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Ivana Croghan, Principal Investigator, Mayo Clinic
mindfulness
Wellness

Study Results

No Results Posted as of Sep 5, 2021