Brain Sensing Device for Stress Management

Overseen By Shawn Fokken, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Mindfulness training, Other programs, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brain-sensing headband called the Muse S™ Headband system to help doctors manage stress during busy times, such as the COVID-19 pandemic. The researchers aim to determine if the device can improve quality of life, reduce stress, and enhance sleep and resilience. Practicing physicians at Mayo Clinic with access to a smartphone or tablet, who are not currently engaged in regular mindfulness training, can participate. Participants will use the headband at least four times a week for three months. As an unphased trial, this study provides a unique opportunity to explore innovative stress management tools and enhance personal well-being.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this brain sensing device is safe for stress management?

Research has shown that the Muse S™ Headband is safe and easy to use. One study found that using this brain-sensing device for 3 to 10 minutes of guided meditation during work hours caused no harm. This indicates the device is well-tolerated and does not lead to serious side effects. The headband tracks brain activity and provides feedback, which can help improve focus and relaxation. Overall, the Muse S™ Headband appears to be a safe choice for managing stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for stress management, which often includes medication and therapy, the Muse S™ Headband system is a wearable device that uses brain-sensing technology to help manage stress. This innovative device provides real-time feedback on brain activity and guides users through meditation sessions, making stress management more interactive and personalized. Researchers are excited about this treatment because it offers a non-invasive, drug-free alternative that empowers individuals to take an active role in their own mental well-being, potentially leading to quicker and more sustainable stress relief.

What evidence suggests that the Muse S™ Headband system is effective for stress management?

Research shows that the Muse S™ Headband, used by participants in this trial, can reduce stress and tiredness while enhancing overall well-being. Studies have found that using the device for guided meditation during work is safe and user-friendly. The headband may also lower anxiety and improve sleep, particularly in breast cancer survivors. By helping users focus their minds, the Muse S™ Headband aims to promote relaxation and better mental health. ^{1 3 6 7 8}

Who Is on the Research Team?

Ivana Croghan, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for practicing physicians at Mayo Clinic who are not pregnant, over 18 years old, able to participate fully and give informed consent. They must have a smartphone or tablet and no health conditions that would affect using the Muse S™ headband. Those with unstable medical/mental conditions, recent mindfulness training, drug trials participation, or other QOL/stress interventions can't join.

Inclusion Criteria

Have access to a smart phone or tablet device

Practicing Physicians at Mayo Clinic

The person did not report being pregnant at the time they gave consent.

Exclusion Criteria

I have been practicing mindfulness regularly for the past 3 weeks.

You have taken a drug that is not yet approved by the government in the last month.

I have not joined any other clinical or research program affecting my quality of life or stress in the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Muse S™ Headband system for mindfulness practices at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months

12 weeks

Self-directed daily use

Follow-up

Participants are monitored for changes in perceived stress, resilience, and quality of life after the treatment period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Muse S™ Headband system

Trial Overview The study tests if the Muse S™ brain sensing headband helps doctors during stressful times by tracking changes in their active and calm states. It aims to see if there's a link between these states and improvements in stress levels, sleep quality, resilience, and overall life quality.

How Is the Trial Designed?

Group I: Practicing Physicians Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

InteraXon, Inc.

Industry Sponsor

Trials

5

Recruited

370+

Cambridge Brain Sciences

Industry Sponsor

Trials

3

Recruited

340+

Citations

1. choosemuse.com choosemuse.com/pages/brain-health-report?srsltid=AfmBOoqN01A7vazU0l5SyhDMAU4GfE5lvBVWnP9yVxtmtcEcm-u4cdtV

2024 Muse Brain Health Report Gen-Z struggles most with stress, loneliness & burnout. Gen-Z reports the highest levels of stress-related attributes with over 50% feeling stressed, burnt out.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041582/

Mindfulness Using a Wearable Brain Sensing Device for ... Study results show that 3 to 10 min of guided meditation during work hours through the use of a brain sensing wearable device is safe and acceptable.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT05199233/Prot_SAP_000.pdf

The Benefit of Mindfulness-Based Intervention Using A ... The Muse-S™ Headband system uses a series of focus attention training methods to train the brain. Each focus attention session can vary in ...

4. trialx.com trialx.com/clinical-trials/listings/285268/muse-s-headband-system-for-improving-anxiety-and-insomnia-among-breast-cancer-survivors/

MUSE-S Headband System for Improving Anxiety and ... The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors. Description. PRIMARY OBJECTIVES: I. To evaluate the ...

5. choosemuse.com choosemuse.com/pages/muse-research?srsltid=AfmBOorYK6W1NdAfUAmMTBwPdwcBZuAlgWH0A0Iknsd-1q00gAnTwMDj

Research | Muse® EEG Mental Fitness & Sleep Headband ... headband significantly reduced stress and fatigue while enhancing overall well-being. Additionally, a 180-day study on individuals experiencing long COVID ...

6. choosemuse.com choosemuse.com/?srsltid=AfmBOooJcP6ko-oLzCxLELOv3R3bewICAe2jZnObs-TkHX7mS2c8Nxed

Muse® EEG Mental Fitness & Sleep Headband Muse's sensors passively measure your brain activity, heart rate, breath, and body movement. Refer back to this data whenever you want. Transform your life.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/aisy.202100099

Trends in Workplace Wearable Technologies and ... d) Muse 2 and Muse S headbands measure brain electrical activity and provide real-time feedback on body performance and mental focus. e ...

8. choosemuse.com choosemuse.com/products/muse-s-athena?srsltid=AfmBOorZqXa30Wb5xYaUPz2CrvaVVY5mkwmaFcQQLXh4xqHGkTNXIkrj

Muse S Athena | Muse® EEG Mental Fitness & Sleep ... Athena is the first and only device to combine EEG + fNIRS technology to measure brain activity, track cognitive effort, and optimize sleep for peak ...