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

NCT04790929 | Completed

• 1 other identifier: 118280
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Perceived Stress Scale

  12 weeks

• Anxiety Questionnaire

  12 weeks

• Depression Questionnaire

  12 weeks

Study Arms (3)

Regular Muse Meditation System - No Coaching

EXPERIMENTAL

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

Regular Muse Meditation System - Additional Coaching

EXPERIMENTAL

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; Behavioral: Meditation Coaching

Controls

NO INTERVENTION

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.

Interventions

Muse DEVICE

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.

Regular Muse Meditation System - Additional Coaching; Regular Muse Meditation System - No Coaching

Meditation Coaching BEHAVIORAL

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.

Regular Muse Meditation System - Additional Coaching

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• If participants do not own a smart phone

Sponsors & Collaborators

• Western University, Canada: lead
• InteraXon, Inc.: collaborator
• Cambridge Brain Sciences: collaborator

Study Sites (1)

Western University

London, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 10, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

CA (1)