Exploring the Effects of Muse and Spire on Stress Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring the Effects of Muse and Spire on Stress Management

Conditions
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Stress

Intervention / Treatment
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* Device: Spire
* Device: Muse headband


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spire device without & with feedback<br>Participants will receive a Spire device with user-feedback switched off within 4 days of enrollment in the study (shipped within 2 business days after they finish enrollment survey). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After two weeks of baseline with user-feedback off (and a 3 day transition period), participants will turn on the user-feedback for the Spire device which would provide a relaxation aid for the participant for the 6 remaining weeks. | Device: Spire<br> <br> |
| Experimental: Muse device & spire device no feedback<br>Participants in this group will also receive Spire device to assess two weeks of baseline stress levels (with user-feedback off). Participants will be given 4 days, after enrollment, to set up their device before the 2 weeks of baseline. The 2 week baseline will start 4 days after enrollment. After these two weeks, participants will continue to use the Spire device with user feedback off for the remaining 6 weeks while they use the Muse device to manage stress through meditation. They will receive the Muse device 3 days before the end of baseline period with set up instructions and will utilize the three last days of baseline to set up their Muse device, Meditation will begin at the end of baseline (week three) and will continue for the remaining 6 weeks. | Device: Spire<br> <br> Device: Muse headband<br> <br> * Other names: InteraXon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout | The change of perceived stress and stress resilience within and between Group 1 and 2 from enrollment to closeout. The change of perceived stress is measured by the Perceived Stress Scale-14 (a validated psychological instrument of 14 items), each each rated on a 5 point scale(0-4) for measuring the respondent's perception of stress in the past month.The PSS-14 ranges from 0 to a high score of 56, with a higher score indicating more stress (worse outcome). The change of stress resilience is measured by the Connor-Davidson Stress Resilience Scale (25 items). It evaluates different aspects of stress coping ability that seeks to understand how well respondents would be able to buffer adverse conditions and cope with stress, each rated on a 5 point scale (0-4). The CD-RISC ranges from 0 to 100, with a higher score representing better stress resilience (a better outcome). | total of 8 weeks (2 weeks of baseline + 6 weeks of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Management, Mindfulness, Meditation, Stress Resilience