Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863690
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2021-04-26
Brief Title:
Assessing the Effects of the Muse Sleep Intervention on Sleep
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Assessing the Effects of the Muse Sleep Intervention on Sleep
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MuseSleep
Brief 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 eg 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
Detailed 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 nights sleep In fact in a recent US health survey of approximately 250000 people 292 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 214 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 eg 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 15-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 Interaxons 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 andor 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
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 eg 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 15-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 Interaxons 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None