Product Testing of the FaceView Mask™: Usability Survey

Not Applicable

Completed

• Conditions: Hearing Disability

• 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.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2022-11-15
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Results First Submitted: 2025-02-07
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Results First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

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

Primary Outcome Measures

Name	Time	Method
Ease of Understanding Another Person	1 day	As recorded on the survey; 1. Difficult; 2. Somewhat difficult; 3. Somewhat easy; 4. Easy

Secondary Outcome Measures

Name	Time	Method
Fit of the Mask	1 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 Mask	1 day	As recorded on the survey; 1. Not comfortable at all; 2. Slightly comfortable; 3. Very comfortable; 4. Extremely comfortable
Ease of Breathing	1 day	As recorded on the survey; 1. Not easy at all; 2. Slightly breathable; 3. Very breathable; 4. Extremely breathable
Ease of Speaking/Communicating	1 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