Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743973
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
InteraXon, Inc.
Cambridge Brain Sciences
Information provided by (Responsible Party):
Ivana Croghan, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Stress, Emotional Sleep Quality of Life Device: Muse S™ Headband system Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 15, 2021
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Frequency adherence to intervention [ Time Frame: 3 months ]
    Summarizing frequency subjects use intervention during active study participation

  2. Duration adherence to intervention [ Time Frame: 3 months ]
    Summarizing duration of time subjects use intervention during active study participation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743973


Contacts
Layout table for location contacts
Contact: Shawn Fokken, CCRP (507) 293-2740 GIMRESEARCHSTUDIES@Mayo.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shawn Fokken, CCRP    507-293-2740    GIMRESEARCHSTUDIES@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
InteraXon, Inc.
Cambridge Brain Sciences
Investigators
Layout table for investigator information
Principal Investigator: Ivana T Croghan, PhD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Ivana Croghan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04743973    
Other Study ID Numbers: 20-007207
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ivana Croghan, Mayo Clinic:
mindfulness
Wellness