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

August 29, 2020 updated by: Joseph C. Kvedar, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • InteraXon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016P000508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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