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Completed

NCT Number: NCT04743973

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

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.

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Key information

Conditions

Stress, Emotional Behavior Behavioral Symptoms Quality of Life Sleep Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muse S™ Headband system

Device

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

Primary outcomes

  1. Frequency Adherence to Intervention

    Time frame: 3 months

    Summarizing frequency subjects use intervention during active study participation (during 3 month study period)

  2. Duration Adherence to Intervention

    Time frame: 3 months

    Summarizing duration of time subjects use intervention during active study participation (during 3 month time period)

Secondary outcomes

  1. Perceived Stress Scale (PSS) Score Difference

    Time frame: 90 days

    The Perceived Stress Scale (PSS) is a 10-item 5-point Likert scale that measures global life stress by assessing the degree (Never, almost never, sometimes, often and very often) to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The score difference is the average change from Day 90 to Baseline.

  2. Resilience Score Difference

    Time frame: 90 days

    Resilience was measured using the Connor-Davison Resilience Scale 10 (CD-RS10). This is a 10-item, 5-point likert scale, validated, scoring system. Scores can range from 0 to 40, with higher scores indicating higher resilience. The CD-RS10 is a reliable means of assessing resilience and most often used in medical and/or disaster studies. Difference from Day 90 to baseline for the resilience score

  3. LASA Score Difference

    Time frame: 90 days

    Quality of Life was measured using the validated Linear Analogue Self-Assessment (LASA) scale. This measure is a 6-item, 11-point likert scale, validated scoring system that measure of quality of life (QOL), in which QOL is conceptualized as a multidimensional construct with five domains (physical, functional, emotional, spiritual, and social). In this measure, each domain can score 0 as the worst possible and 10 being the best possible. The total score for QoL could range from 0 to 60 with higher score indicating greater QoL. Change from Day 90 to Baseline for the LASA score

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Cambridge Brain Sciences
  • InteraXon, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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