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

NCT ID: NCT04743973

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress, Emotional Sleep Quality of Life

Keywords

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mindfulness Wellness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Muse S™ Headband system

Intervention Type DEVICE

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

Interventions

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Muse S™ Headband system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InteraXon, Inc.

INDUSTRY

Sponsor Role collaborator

Cambridge Brain Sciences

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ivana T Croghan, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivana T Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 36960553 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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20-007207

Identifier Type: -

Identifier Source: org_study_id