MedPath

Product Testing of the FaceView Mask™: Usability Survey

Not Applicable
Completed
Conditions
Hearing Disability
Interventions
Device: FaceView Mask™
Device: conventional surgical N95 respirator
Registration Number
NCT04854694
Lead Sponsor
University of Arkansas
Brief Summary

The study aims to gather participants' perceptions of the novel transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following fitting of the masks, participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.

Detailed Description

The investigators will recruit adult participants to complete a usability survey on a transparent surgical N95 respirator (i.e., FaceView mask) designed to improve communication. The study aims to gather participants' perceptions of the novel transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following fitting of the masks (5 minutes wear time each), the participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
202
Inclusion Criteria
  • at least 18 years old
  • have no health conditions that would prevent them from safely wearing an N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)
  • read in English and communicate in English or American Sign Language
  • be able to provide or arrange their own transportation to the study location
Exclusion Criteria
  • Children are to be excluded from the proposed research project because the current FaceView Mask™ is designed for adults
  • Adults who are non-English communicators
  • Any adult with health conditions that would prevent them from safely wearing an N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
All SubjectsFaceView Mask™All participants will be fit tested for the masks to ensure that the appropriate size is used. Some participants will wear the FaceView Mask™ (first) for 5 minutes before wearing the conventional surgical N95 respirator for 5 minutes. Others will wear the conventional surgical N95 respirator (first) for 5 minutes before wearing the FaceView Mask™ for 5 minutes. All subjects will complete the study survey after exposure to the interventions.
All Subjectsconventional surgical N95 respiratorAll participants will be fit tested for the masks to ensure that the appropriate size is used. Some participants will wear the FaceView Mask™ (first) for 5 minutes before wearing the conventional surgical N95 respirator for 5 minutes. Others will wear the conventional surgical N95 respirator (first) for 5 minutes before wearing the FaceView Mask™ for 5 minutes. All subjects will complete the study survey after exposure to the interventions.
Primary Outcome Measures
NameTimeMethod
Ease of Understanding Another Person1 day

As recorded on the survey

1. Difficult

2. Somewhat difficult

3. Somewhat easy

4. Easy

Secondary Outcome Measures
NameTimeMethod
Fit of the Mask1 day

As recorded on the survey

1. Extremely small

2. Slightly too small

3. Fits well

4. Slightly too large

5. Extremely large

Comfort of the Mask1 day

As recorded on the survey

1. Not comfortable at all

2. Slightly comfortable

3. Very comfortable

4. Extremely comfortable

Ease of Breathing1 day

As recorded on the survey

1. Not easy at all

2. Slightly breathable

3. Very breathable

4. Extremely breathable

Ease of Speaking/Communicating1 day

As recorded on the survey

1. Difficult

2. Somewhat difficult

3. Somewhat easy

4. Easy

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

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