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| Name | Class |
|---|---|
| InteraXon, Inc. | INDUSTRY |
| Cambridge Brain Sciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practicing Physicians | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muse S™ Headband system | Device | Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency Adherence to Intervention | Summarizing frequency subjects use intervention during active study participation (during 3 month study period) | 3 months |
| Duration Adherence to Intervention | Summarizing duration of time subjects use intervention during active study participation (during 3 month time period) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS) Score Difference | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T Croghan, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36960553 | Result | Ghosh K, Nanda S, Hurt RT, Schroeder DR, West CP, Fischer KM, Bauer BA, Fokken SC, Ganesh R, Hanson JL, Lindeen SA, Pruthi S, Croghan IT. Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231162308. doi: 10.1177/21501319231162308. |
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Participants who were patients in the long COVID-19 clinic were invited to participate if they were found to be eligible for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Muse-S Group | Participants used Muse-S for the study period (up to 3 months). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Muse-S Group | Participants used Muse-S for the study period (up to 3 months). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency Adherence to Intervention | Summarizing frequency subjects use intervention during active study participation (during 3 month study period) | Posted | Mean | Standard Deviation | times used | 3 months |
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During the treatment phase (3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Muse-S Group | Participants used Muse-S for the study period (up to 3 months). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ivana T. Croghan | Mayo Clinic | 507-284-2511 | GIMRESEARCHSTUDIES@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2024 | Nov 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2024 | Nov 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 90 days |
| Resilience Score Difference | 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 | 90 days |
| LASA Score Difference | 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 | 90 days |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Sex of participant at birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Hispanic or Latino Ethnicity that is self-identified by participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Self-identified race by participants | Count of Participants | Participants |
|
| Perceived Stress Scale baseline score | The Perceived Stress Scale (PSS) is a 10-item Likert scale that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. | Mean | Standard Deviation | units on a scale |
|
| Resilience baseline score | Resilience was measured using the Connor-Davison Resilience Scale 10 (CD-RS10). This is a 10-item, likert scale, validated, scoring system. With the higher score indicating higher resilience. The CD-RS10 is a reliable means of assessing resilience and most often used in medical and/or disaster studies | Mean | Standard Deviation | units on a scale |
|
| LASA baseline score | Quality of Life was measured using the validated Linear Analogue Self-Assessment (LASA) scale. This measure is a six-item measure of quality of life (QOL), in which QOL is conceptualized as a multidimensional construct with five domains (physical, functional, emotional, spiritual, and social). This is a 11-item Likert scale (0 to 10) with 0 being the worst possible and 10 being the best possible. | Mean | Standard Deviation | units on a scale |
|
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| Primary | Duration Adherence to Intervention | Summarizing duration of time subjects use intervention during active study participation (during 3 month time period) | Posted | Mean | Standard Deviation | minutes | 3 months |
|
|
|
| Secondary | Perceived Stress Scale (PSS) Score Difference | 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. | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
|
|
| Secondary | Resilience Score Difference | 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 | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
|
|
| Secondary | LASA Score Difference | 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 | Posted | Mean | Standard Deviation | units on a scale | 90 days |
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| 0 |
| 40 |
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| 1 |
| 40 |
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