Trial Outcomes & Findings for A Study to Asses Wellness Using a Brain Sensing Device on Physicians (NCT NCT04743973)

NCT ID: NCT04743973

Last Updated: 2024-12-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-12-27

Participant Flow

Participants who were patients in the long COVID-19 clinic were invited to participate if they were found to be eligible for the study.

Participant milestones

Measure	Muse-S Group Participants used Muse-S for the study period (up to 3 months).
Overall Study STARTED	40
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Muse-S Group Participants used Muse-S for the study period (up to 3 months).
Overall Study Withdrawal by Subject	5

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Muse-S Group n=40 Participants Participants used Muse-S for the study period (up to 3 months).
Age, Continuous	41.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Perceived Stress Scale baseline score	11.1 units on a scale STANDARD_DEVIATION 3.94 • n=5 Participants
Resilience baseline score	27.4 units on a scale STANDARD_DEVIATION 5.01 • n=5 Participants
LASA baseline score	39.2 units on a scale STANDARD_DEVIATION 6.59 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Muse-S Group n=40 Participants Participants used Muse-S for the study period (up to 3 months).
Frequency Adherence to Intervention	57.8 times used Standard Deviation 30.6

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Muse-S Group n=40 Participants Participants used Muse-S for the study period (up to 3 months).
Duration Adherence to Intervention	5.9 minutes Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Muse-S Group n=36 Participants Participants used Muse-S for the study period (up to 3 months).
Perceived Stress Scale (PSS) Score Difference	-2.1 units on a scale Standard Deviation 3.81

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Muse-S Group n=36 Participants Participants used Muse-S for the study period (up to 3 months).
Resilience Score Difference	1.4 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Muse-S Group n=36 Participants Participants used Muse-S for the study period (up to 3 months).
LASA Score Difference	2.7 units on a scale Standard Deviation 6.0

Adverse Events

Muse-S Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Muse-S Group n=40 participants at risk Participants used Muse-S for the study period (up to 3 months).
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • During the treatment phase (3 months)

Additional Information

Dr. Ivana T. Croghan

Mayo Clinic

Phone: 507-284-2511

Email: GIMRESEARCHSTUDIES@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place