MediationMuseSleepNCT04863690
Assessing the Effects of the Muse Sleep Intervention on Sleep
A study testing Meditation, Digital Coaching and Digital Coaching plus Human Coaching in people with Mediation and Coaching, run by Western University, Canada at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- What is being tested?
- Meditation, Digital Coaching and Digital Coaching plus Human Coaching
- Type of treatment
- 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 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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).
- Being tested
- Meditation, Digital Coaching, Digital Coaching plus Human Coaching
- Keywords
- Meditation, Sleep, Cognition
- Medical subject headings
- Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
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.
Digital CoachingBehavioural
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.
Digital Coaching plus Human CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention System - No Coaching | Experimental | 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. Receives: Behavioral: Meditation |
| Sleep Intervention System - Plus Digital Coaching | Experimental | 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. Receives: Behavioral: Meditation; Behavioral: Digital Coaching |
| Sleep Intervention System - Plus Digital Coaching plus Human Coaching | Experimental | 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. 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: Behavioral: Meditation; Behavioral: Digital Coaching; Behavioral: Digital Coaching plus Human Coaching |
| Control | 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Score on the Cambridge Brain Sciences
Secondary outcome measures will be score on the Cambridge Brain Sciences (CBS) cognitive battery. The 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 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 MediationStudies 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
- 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
- Investigators
- Adrian M Owen, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863690
- Sponsor's protocol ID
- 118355
- Acronym
- MuseSleep
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Sleep Intervention on Sleep
- ClinicalTrials.gov ID
- NCT04863690
- Acronym / sponsor ID
- MuseSleep / 118355
- Keywords
- Meditation, Sleep, Cognition
- 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
- 28 Apr 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.
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.
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 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention System - No Coaching | Experimental | Behavioral: MeditationParticipants 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 | Experimental | Behavioral: Meditation, Behavioral: Digital CoachingThe 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 | Experimental | Behavioral: Meditation, Behavioral: Digital Coaching, Behavioral: Digital Coaching plus Human CoachingThe 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 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 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. |
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 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.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MeditationParticipants 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. | Behavioural | Sleep Intervention System - No Coaching, Sleep Intervention System - Plus Digital Coaching, Sleep Intervention System - Plus Digital Coaching plus Human Coaching |
| Digital CoachingAll 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. | Behavioural | Sleep Intervention System - Plus Digital Coaching, Sleep Intervention System - Plus Digital Coaching plus Human Coaching |
| Digital Coaching plus Human CoachingAll 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. | Behavioural | Sleep Intervention System - Plus Digital Coaching plus Human Coaching |
Primary outcome
Sleep Scores
Time frame: 12 weeks
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.
1 secondary outcome
Score on the Cambridge Brain Sciences
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: No
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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.
Adrian M Owen, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation, Digital Coaching and Digital Coaching plus Human Coaching in people with Mediation and Coaching, 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 1 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?
Sleep Scores (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.