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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04743973
• Other study ID #: 20-007207
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Sleep
• Stress, Emotional

Intervention

Device:
• Muse S™ Headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Cambridge Brain Sciences, InteraXon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency adherence to intervention	Summarizing frequency subjects use intervention during active study participation	3 months
Primary	Duration adherence to intervention	Summarizing duration of time subjects use intervention during active study participation	3 months

External Links

•   Mayo Clinic Clinical Trials