NCT04743973

A Study to Asses Wellness Using a Brain Sensing Device on Physicians

Completed NA Results posted Last updated 27 December 2024

What this trial tests

NA trial testing Muse S™ Headband system in Stress, Emotional in 40 participants. Completed in 1 September 2024.

Timeline

15 August 2021

Primary endpoint
1 August 2024

1 September 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	15 August 2021
Primary completion	1 August 2024
Estimated completion	1 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Muse S™ Headband system

Conditions studied

• Stress, Emotional — all drugs for Stress, Emotional →
• Sleep — all drugs for Sleep →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Stress, Emotional or Sleep. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency Adherence to Intervention Primary · 3 months

Summarizing frequency subjects use intervention during active study participation (during 3 month study period)

Group	Value	95% CI
Muse-S Group	57.8	± 30.6

Duration Adherence to Intervention Primary · 3 months

Summarizing duration of time subjects use intervention during active study participation (during 3 month time period)

Group	Value	95% CI
Muse-S Group	5.9	± 1.9

Perceived Stress Scale (PSS) Score Difference Secondary · 90 days

The Perceived Stress Scale (PSS) is a 10-item 5-point Likert scale that measures global life stress by assessing the degree (Never, almost never, sometimes, often and very often) to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The score difference is the average change from Day 90 to Baseline.

Group	Value	95% CI
Muse-S Group	-2.1	± 3.81

Resilience Score Difference Secondary · 90 days

Resilience was measured using the Connor-Davison Resilience Scale 10 (CD-RS10). This is a 10-item, 5-point likert scale, validated, scoring system. Scores can range from 0 to 40, with higher scores indicating higher resilience. The CD-RS10 is a reliable means of assessing resilience and most often used in medical and/or disaster studies. Difference from Day 90 to baseline for the resilience score

Group	Value	95% CI
Muse-S Group	1.4	± 3.9

LASA Score Difference Secondary · 90 days

Quality of Life was measured using the validated Linear Analogue Self-Assessment (LASA) scale. This measure is a 6-item, 11-point likert scale, validated scoring system that measure of quality of life (QOL), in which QOL is conceptualized as a multidimensional construct with five domains (physical, functional, emotional, spiritual, and social). In this measure, each domain can score 0 as the worst possible and 10 being the best possible. The total score for QoL could range from 0 to 60 with higher score indicating greater QoL. Change from Day 90 to Baseline for the LASA score

Group	Value	95% CI
Muse-S Group	2.7	± 6.0

Adverse events — posted to ClinicalTrials.gov

Time frame: During the treatment phase (3 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Muse-S Group

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (1 terms — click to expand)

Reaction	System	Muse-S Group
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04743973 adverse events section.

Sponsor's own description

A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program.
   Ghosh K, Nanda S, Hurt RT, Schroeder DR, et al · · 2023 · cited 8× · PMID 36960553 · DOI 10.1177/21501319231162308