Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790929
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2021-03-01
Brief Title:
Assessing the Effects of the Muse Meditation System on Cognition and Well-being
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Assessing the Effects of the Muse Meditation System on Cognition and Well-being
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:
MuseCog
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
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 15-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 Interaxons 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 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 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 eg 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
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 15-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 Interaxons 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 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 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 eg 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 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