Assessing the Effects of the Muse Sleep Intervention on Sleep

NCT04863690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-25

No results posted yet for this study

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.

Conditions

  • Mediation
  • Coaching

Interventions

BEHAVIORAL

Meditation

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.

BEHAVIORAL

Digital Coaching

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.

BEHAVIORAL

Digital Coaching plus Human Coaching

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.

Sponsors & Collaborators

  • InteraXon, Inc.

    collaborator INDUSTRY
  • Cambridge Brain Sciences

    collaborator INDUSTRY
  • Western University, Canada

    lead OTHER

Principal Investigators

  • Adrian M Owen, PhD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-05-01
Completion
2022-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863690 on ClinicalTrials.gov