Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04863690 |
| Other study ID # |
118355 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Western University, Canada |
| Contact |
Adrian M Owen, PhD |
| Phone |
+1 05198596861 |
| Email |
adrian.owen[@]uwo.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, we will examine whether use of the Sleep Intervention protocol marketed by
Interaxon (the 'Muse'), leads to improvements in sleep quality (e.g. decreased latency to
sleep, improved sleep duration), as well as knock-on improvements on measures of mindfulness,
improvement in quality of life scores, reduction in perceived stress levels, anxiety,
improvements in cognitive performance, improvement in markers relevant for safety, and
increased success in the workplace in healthy participants.
Description:
We all sleep, hopefully, every single day. Regular and sufficient sleep helps maintain
numerous aspects of physical and mental health, but countless ordinary life circumstances,
such as parenthood, demanding professions, studying, illness, or lifestyle choices often
prevent people from getting a full night's sleep. In fact, in a recent US health survey of
approximately 250000 people, 29.2% of respondents reported getting less than an average of 6
hours of sleep per night. Individuals who sleep this little on a day-to-day basis are
considered to be experiencing chronic partial sleep deprivation (SD) (also known as sleep
restriction), which, in a laboratory setting, has been associated with impaired physiological
and cognitive functioning. It has been estimated that the productivity lost annually due to
chronic partial SD costs an estimated $21.4 billion in Canada alone.
Interaxon markets a non-invasive head-worn device 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 Stroop Task. It
has also been shown to improve physiological markers associated with improved relaxation and
cognition. Muse has been shown to have EEG signal comparable to a clinical grade EEG.
What is not known, is whether use of the Muse device can actually improve sleep quality and
if so, in what ways. Thus far, some reports have suggested that the Muse Meditation device
can improve relaxation, but a comprehensive evaluation of sleep has not been undertaken in a
relatively large sample of healthy volunteers.
In this study, we will examine whether use of the Muse Sleep Intervention by healthy
participants, leads to improvements in sleep quality (e.g. decreased latency to sleep,
improved sleep duration), as well as knock-on improvements on measures of mindfulness,
improvement in quality of life scores, reduction in perceived stress levels, anxiety,
improvements in cognitive performance, improvement in markers relevant for safety, and
increased success in the workplace. We will examine whether these changes are associated with
changes in heart rhythm as measured by the Muse on board PPG sensor.
360 participants working in a large engineering firm, Hatch, will use the Muse Sleep
Intervention to meditate before sleep over the course of 6 weeks.
The participants will be randomly divided into 4 groups with 90 participants in each group
(see below).
Group 1 will use the Muse Sleep Intervention system with no coaching.
Group 2 will use the Muse Sleep Intervention system with digital coaching.
Group 3 will use the Muse Sleep Intervention system with digital coaching and additional
human group online coaching.
Group 4 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: Sleep Intervention System - No Coaching Participants will join a 1.5-hour virtual
onboarding session where they will be trained on how to use the Muse S device and will
complete their first Muse session. Participants will be asked to use either the Muse Mind
Meditation, Muse Sleep Journeys, Go to Sleep Soundscapes or Go to Sleep Guidance each evening
as part of their bedtime routine to help them prepare to sleep. In addition, participants may
use any part of the Muse App (Mind, Heart, Breath, Body, Guided or Go to Sleep meditations),
as often as they like to help them fall asleep, go back to sleep, or as a meditation practice
during the daytime. All Participants will also be asked to do the Muse Mind meditation for a
minimum of 5 minutes per day, a minimum of 5 days per week, for 6 weeks. If they also wish to
use the Muse system more frequently (day or night), they will be encouraged to do so and will
be able to choose between several styles of available meditation (Mind, Heart, Breath, Body,
Guided or Go to Sleep meditations). Participants will be asked to also wear their Muse device
while they sleep, as often as they like in order to track their sleep. Participants will have
unlimited access to Muse Customer Care via phone, email, and video where appropriate during
normal business hours.
Group 2: Sleep Intervention System - Plus Digital Coaching The procedure will be identical to
Group 1 above, but in addition, all participants will also work through the content in the
Muse S Sleep Coaching course, and implement the sleep hygiene and habit changes recommended
through the course that they find reasonable and effective for their situation.
Group 3: Sleep Intervention System - Plus Digital Coaching plus Human Coaching. The procedure
will be identical to Group 2 above, but in addition, all participants will be asked to join
regular online coaching sessions. Participants will be divided into 9 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 and how to support sleep. Coaching will take place
virtually using Interaxon's Zoom account.
Group 4: 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 and (depending on
group), sleep quality.
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).
