Assessing the Effects of the Muse Meditation System on Cognition and Well-being (MuseCog)

Interaxon markets a head-worn EEG biofeedback device ('Muse') to encourage and aid effective meditation and sleep. This device has been previously shown to improve workplace wellness, fatigue and quality of life, and performance on the Stroop Task. It has also been shown to improve physiological markers associated with improved relaxation. What is not known, is whether the use of the Muse devices can improve cognitive function. In this study, the investigators will examine whether use of the Muse Meditation system by healthy participants, leads to improvements in cognition, sleep quality, mindfulness, improvement in quality of life scores, reduction in perceived stress levels, and improvement in cognitive markers relevant for safety and increased success in the workplace.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Change
• Intervention / Treatment: Device: Muse; Behavioral: Meditation Coaching

Detailed Description

Meditation is a non-invasive technique that has recently gained significant popularity for its ability to effect positive change on the mind and body. Even a brief (4 sessions) meditation training intervention has been shown to lead to improvements in various areas of cognitive function [1], stress and anxiety, and it has been shown to improve sleep in older adults better than a sleep hygiene course [2]. Mindfulness is now being extensively used in the workplace to promote various aspects of workplace wellness [3], and workplace health and safety [4].

Interaxon markets a head-worn EEG biofeedback device ('Muse') to encourage and aid effective meditation and sleep. This device has been previously shown to improve workplace wellness, fatigue and quality of life, and performance on the Stroop Task. It has also been shown to improve physiological markers associated with improved relaxation.

In this study, the investigators will examine whether use of the Muse Meditation system by healthy participants, leads to improvements in cognition, sleep quality, mindfulness, improvement in quality of life scores, reduction in perceived stress levels, and improvement in cognitive markers relevant for safety and increased success in the workplace.

240 participants will be randomly divided into 3 groups with 80 participants in each group (see below).

Group 1 will use the Muse Meditation system with no coaching.

Group 2 will use the Muse Meditation system with additional online coaching.

Group 3 will be a control group and will not use any of the Muse Meditation systems

On day 1 of the Study, all participants will complete the Cambridge Brain Sciences online cognitive assessment battery, plus a longer questionnaire about stress levels, workplace wellness, quality of life, mindfulness and sleep quality. They will then begin the 6-week study according to their following Group assignments:

Group 1: Regular Muse Meditation System - No Coaching:

Participants will join a 1.5-hour virtual onboarding session where they will complete their first Muse session. Participants will then be asked to use the Muse Meditation system for a minimum of 5 minutes a day (in one or multiple sessions), a minimum of 5 days a week, for 6 weeks. If they wish to use the system more frequently within the 6 weeks, they will be encouraged to do so and will be able to choose between all the styles of meditation available in the Muse Meditation System (Mind, Heart, Breath, Body, Guided or Sleep Journeys). For any challenges that arise, participants will have unlimited access to Muse Customer Care via phone, email, and video where appropriate during normal business hours.

Group 2: Regular Muse Meditation System - Additional Coaching The procedure will be identical to Group 1 above, but in addition, all participants will be asked to join regular online coaching sessions. Participants will be divided into 8 cohorts of 10 people per cohort. Each cohort will be offered group coaching once per week. Coaches will be versed in Mindfulness and how to use Muse. Coaching will take place virtually using Interaxon's Zoom account. Throughout the coaching, all participants will be referred to via their first names or their anonymized login names. In addition, for any challenges that arise, participants will have unlimited access to Muse Customer Care via phone, email, and video where appropriate during normal business hours.

Group 3: Controls The participants in the control group will receive a Muse Device, which they will be free to keep at the end of the study. They will be asked not to open and/or use the Muse device until the entire study is complete. On day 1 of the Study, they will complete the Cambridge Brain Sciences online cognitive assessment battery, plus a longer questionnaire about stress levels, workplace wellness, quality of life, mindfulness, anxiety and depression and sleep quality. At the completion of the study controls will be offered optional, free group coaching sessions if they complete the study requirements.

At the end of Week 6 (at the completion of the main study period), all participants will be reassessed using the Cambridge Brain Sciences online cognitive assessment battery , and the longer questionnaire about stress levels, workplace wellness, quality of life, mindfulness and sleep quality.

All participants will also complete a brief debriefing questionnaire at the end of Week 6, reporting their experiences about the study.

They will again be assessed using the Cambridge Brain Sciences online cognitive assessment battery, and the longer questionnaire about stress levels, workplace wellness, quality of life, mindfulness and sleep quality at the end of Week 12 (6 weeks after completing the main study period).

Hypothesis 1: Using the Muse Meditation system for 6 weeks will yield improvements in cognitive performance on the Cambridge Brain Sciences battery, improvements in self-reported sleep quality (e.g. decreased latency to sleep, improved sleep duration), improvements on measures of mindfulness, improvement in quality of life scores, reduction in perceived stress levels, reduction in anxiety, and improvement in cognitive markers (derived from the Cambridge Brain Sciences scores) relevant for safety and increased success in the workplace. The investigators expect to see these changes in both experimental groups relative to the control group.

Hypothesis 2: These changes will persist well beyond the period of the study and will be detectible at the 12-week follow-up session.

Hypothesis 3: The participants who use the Muse Meditation system and have additional coaching (Group 2), will experience improvements in cognition, stress, anxiety, and other quality of life measures over and above those experienced by those who use the Muse Meditation system with no coaching (Group 1).

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian A Professor, PhD; Phone Number: 84672 519-661-2111; Email: adrian.owen@uwo.ca
• Study Contact Backup: Name: Dawn Pavich; Phone Number: 84672 519-661-2111; Email: dpavich@uwo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The study will be open only to all Hatch Inc employees in Canada.

Exclusion Criteria:

If participants do not own a smart phone

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regular Muse Meditation System - No Coaching; Participants will join a 1.5-hour virtual onboarding session where they will complete their first Muse session. Participants will then be asked to use the Muse Meditation system for a minimum of 5 minutes a day (in one or multiple sessions), a minimum of 5 days a week, for 6 weeks. If they wish to use the system more frequently within the 6 weeks, they will be encouraged to do so and will be able to choose between all the styles of meditation available in the Muse Meditation System (Mind, Heart, Breath, Body, Guided or Sleep Journeys). For any challenges that arise, participants will have unlimited access to Muse Customer Care via phone, email, and video where appropriate during normal business hours.	Device: Muse; Interaxon markets a head-worn EEG biofeedback device ('Muse') to encourage and aid effective meditation and sleep. This device has been previously shown to improve workplace wellness, fatigue and quality of life, and performance on the Stroop Task. It has also been shown to improve physiological markers associated with improved relaxation. Muse has been shown to have an EEG signal comparable to a clinical grade EEG.
Experimental: Regular Muse Meditation System - Additional Coaching; The procedure will be identical to Group 1 above, but in addition, all participants will be asked to join regular online coaching sessions. Participants will be divided into 8 cohorts of 10 people per cohort. Each cohort will be offered group coaching once per week. Coaches will be versed in Mindfulness and how to use Muse. Coaching will take place virtually using Interaxon's Zoom account. Throughout the coaching, all participants will be referred to via their first names or their anonymized login names. In addition, for any challenges that arise, participants will have unlimited access to Muse Customer Care via phone, email, and video where appropriate during normal business hours.	Device: Muse; Interaxon markets a head-worn EEG biofeedback device ('Muse') to encourage and aid effective meditation and sleep. This device has been previously shown to improve workplace wellness, fatigue and quality of life, and performance on the Stroop Task. It has also been shown to improve physiological markers associated with improved relaxation. Muse has been shown to have an EEG signal comparable to a clinical grade EEG.; Behavioral: Meditation Coaching; Participants will be asked to use the Muse Meditation system for a minimum of 5 minutes a day (in one or multiple sessions), a minimum of 5 days a week, for 6 weeks and will be coached in how to do so. Coaches will be versed in Mindfulness and how to use Muse. Coaching will take place virtually using Interaxon's Zoom account.
No Intervention: Controls; The participants in the control group will receive a Muse Device, which they will be free to keep at the end of the study. They will be asked not to open and/or use the Muse device until the entire study is complete. On day 1 of the Study, they will complete the Cambridge Brain Sciences online cognitive assessment battery, plus a longer questionnaire about stress levels, workplace wellness, quality of life, mindfulness, anxiety and depression and sleep quality. At the completion of the study controls will be offered optional, free group coaching sessions if they complete the study requirements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	The primary outcome will be scores on the Cambridge Brain Sciences (CBS) cognitive battery The Cambridge Brain Sciences (CBS) battery assesses aspects of memory, attention, planning, and reasoning, using a web-based interface that can be self-administered at home through any internet browser.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	Quality of life will be scoresd on self-reported Perceived Stress Scale.	12 weeks
Anxiety Questionnaire	Anxiety will be scored using General Anxiety Disorder 7 Scale	12 weeks
Depression Questionnaire	Depression will be measured using will be scored using Patient Health Questionnaire 9	12 weeks

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: InteraXon, Inc.; Cambridge Brain Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2021
• Primary Completion (Anticipated): June 14, 2021
• Study Completion (Anticipated): June 14, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 118280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No