Assessing the Effects of the Muse Sleep Intervention on Sleep
MuseSleep
1 other identifier
interventional
150
1 country
1
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 25, 2024
July 1, 2024
1 year
April 26, 2021
July 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Scores
The primary outcome will be scores on the Sleep Questionnaire. This questionnaire includes the Pittsburgh Sleep Quality Index which is the most widely accepted and validated self-report method for assessing changes in sleeping patterns.
12 weeks
Secondary Outcomes (1)
Score on the Cambridge Brain Sciences
12 weeks
Study Arms (4)
Sleep Intervention System - No Coaching
EXPERIMENTALParticipants 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.
Sleep Intervention System - Plus Digital Coaching
EXPERIMENTALThe 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.
Sleep Intervention System - Plus Digital Coaching plus Human Coaching
EXPERIMENTALThe 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. 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.
Control
NO INTERVENTIONThe 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 completion of the study controls will be offered optional, free group coaching sessions if they complete the study requirements.
Interventions
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.
All participants will 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.
All participants will 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. All participants will also 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.
Eligibility Criteria
You may qualify if:
- The study will be open to all Hatch employees in Canada. Hatch is a large engineering firm in Canada. Hatch currently has 4406 Canadian employees and therefore our sample size represents approximately 10% of the population.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western University, Canadalead
- InteraXon, Inc.collaborator
- Cambridge Brain Sciencescollaborator
Study Sites (1)
Western University
London, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian M Owen, PhD
Western University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
April 28, 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
Data Sharing
- IPD Sharing
- Will not share