Cognitive ChangeMuseCogNCT04790929
Assessing the Effects of the Muse Meditation System on Cognition and Well-being
A study testing Muse and Meditation Coaching in people with Cognitive Change, run by Western University, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Muse and Meditation Coaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will be open only to all Hatch Inc employees in Canada.
Who cannot join
- If participants do not own a smart phone
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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).
- Conditions
- Cognitive Change
- Being tested
- Muse, Meditation Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MuseDevice
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. Muse has been shown to have an EEG signal comparable to a clinical grade EEG.
Meditation CoachingBehavioural
Participants will 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 and will be coached in how to do so. Coaches will be versed in Mindfulness and how to use Muse. Coaching will take place virtually using Interaxon's Zoom account.
| Study group | Role | What they receive |
|---|---|---|
| Regular Muse Meditation System - No Coaching | Experimental | 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. Receives: Device: Muse |
| Regular Muse Meditation System - Additional Coaching | Experimental | 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. Receives: Device: Muse; Behavioral: Meditation Coaching |
| Controls | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
The primary outcome will be scores on the Cambridge Brain Sciences (CBS) cognitive battery The Cambridge Brain Sciences (CBS) battery assesses aspects of memory, attention, planning, and reasoning, using a web-based interface that can be self-administered at home through any internet browser.
Measured: 12 weeks
Secondary outcomes (3)
Perceived Stress Scale
Quality of life will be scoresd on self-reported Perceived Stress Scale.
Measured: 12 weeks
Anxiety Questionnaire
Anxiety will be scored using General Anxiety Disorder 7 Scale
Measured: 12 weeks
Depression Questionnaire
Depression will be measured using will be scored using Patient Health Questionnaire 9
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 May 2021
- Primary completion1 May 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- InteraXon, Inc., Cambridge Brain Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790929
- Sponsor's protocol ID
- 118280
- Acronym
- MuseCog
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of the Muse Meditation System on Cognition and Well-being
- ClinicalTrials.gov ID
- NCT04790929
- Acronym / sponsor ID
- MuseCog / 118280
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- InteraXon, Inc., Cambridge Brain Sciences
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Regular Muse Meditation System - No Coaching | Experimental | Device: MuseParticipants 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. |
| Regular Muse Meditation System - Additional Coaching | Experimental | Device: Muse, Behavioral: Meditation CoachingThe 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. |
| Controls | No intervention | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will be open only to all Hatch Inc employees in Canada.
Key exclusion criteria (2 listed)
- If participants do not own a smart phone
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MuseInteraxon 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. Muse has been shown to have an EEG signal comparable to a clinical grade EEG. | Device | Regular Muse Meditation System - Additional Coaching, Regular Muse Meditation System - No Coaching |
| Meditation CoachingParticipants will 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 and will be coached in how to do so. Coaches will be versed in Mindfulness and how to use Muse. Coaching will take place virtually using Interaxon's Zoom account. | Behavioural | Regular Muse Meditation System - Additional Coaching |
Primary outcome
Cognition
Time frame: 12 weeks
The primary outcome will be scores on the Cambridge Brain Sciences (CBS) cognitive battery The Cambridge Brain Sciences (CBS) battery assesses aspects of memory, attention, planning, and reasoning, using a web-based interface that can be self-administered at home through any internet browser.
3 secondary outcomes
Perceived Stress Scale
Time frame: 12 weeks
Anxiety Questionnaire
Time frame: 12 weeks
Depression Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muse and Meditation Coaching in people with Cognitive Change, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.