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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Stress

Treatments

Device: Spire
Device: Muse headband

Study type

Interventional

Funder types

Other

Identifiers

NCT02786771
2016P000508

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

126 participants in 2 patient groups

Spire device without & with feedback
Experimental group
Description:
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.
Treatment:
Device: Spire
Muse device & spire device no feedback
Experimental group
Description:
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.
Treatment:
Device: Spire
Device: Muse headband

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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