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Exploring the Effects of Muse and Spire on Stress Management (Stressless)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786771
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : May 16, 2018
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph C. Kvedar, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Stress Device: Spire Device: Muse headband Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploring the Effects of Muse and Spire on Stress Management
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arm Intervention/treatment
Experimental: Spire device without & with feedback
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
Experimental: Muse device & spire device no feedback
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
Device: Muse headband
Other Name: InteraXon




Primary Outcome Measures :
  1. Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout [ Time Frame: total of 8 weeks (2 weeks of baseline + 6 weeks of intervention) ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Additional Information:
Publications:

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Responsible Party: Joseph C. Kvedar, Dermatologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02786771    
Other Study ID Numbers: 2016P000508
First Posted: June 1, 2016    Key Record Dates
Results First Posted: May 16, 2018
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joseph C. Kvedar, Massachusetts General Hospital:
Stress Management
Mindfulness
Meditation
Stress Resilience