Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04790929 |
| Other study ID # |
118280 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
June 14, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Western University, Canada |
| Contact |
Adrian A Professor, PhD |
| Phone |
519-661-2111 |
| Email |
adrian.owen[@]uwo.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
