Clinical trial NCT02786771: Exploring the Effects of Muse and Spire on Stress Management
Official title: Exploring the Effects of Muse and Spire on Stress Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress Management
Mindfulness
Meditation
Stress Resilience
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to evaluate the effectiveness of Spire and Muse on stress management. The study will be implemented as a 2-arm randomized controlled pilot study to assess the effect of either device on stress management from the end of baseline to closeout.

Detailed description: Both Muse and Spire are recent technologies that could improve our understanding of stress management and enhance quality of healthcare. The goal of this study is to evaluate if Spire and Muse help individuals self-manage stress. Spire has been designed as a discrete clip-on tracker that monitors changes in respiration rate. With the companion app, this device displays breathing rates in real time and alerts the user through push notification in times of tension. Studies show that controlled breathing reduces stress. On the other hand, Muse is a headset device that uses EEG (electroencephalogram) sensors that measures electric brain frequencies. Muse guides the user in a form of simplified meditation by giving feedback in real time (i.e. calm, neutral, active) and audio clues to improve concentration. Previous studies have shown that engaging in meditation has the potential to reduce anxiety and stress.

Eligibility criteria: Inclusion Criteria:

* Registered for Partners HealthCare Connected Health Symposium 2016
* Over 18 years old
* Able to read and speak English
* Own a smartphone and have internet connection
* Willing to wear a Spire device during all hours (except sleep)
* Willing to use the Muse device (Group 2 ONLY)
* Willing to participate in a research study and sign the consent form

Exclusion Criteria:

* Not Registered for Partners HealthCare Connected Health Symposium 2016
* Under 18 years old
* Not able to read and speak English
* Do not own a smartphone and have internet connection
* Not willing to wear a Spire device during all hours (except sleep)
* Not willing to use the Muse device (Group 2 ONLY)
* Not willing to sign the consent form

Primary outcomes:
measure: Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout
timeFrame: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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