Product Testing of the FaceView Mask™: Usability Survey

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.

Study Overview

• Status: Completed
• Conditions: Hearing Disability
• Intervention / Treatment: Device: FaceView Mask™; Device: conventional surgical N95 respirator

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 Type: Observational
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

A goal of 200 participants is desired with a minimum of 125 to meet study targets. We will be contacting known persons (not cold contacts) with ability to share study brochure by e-mail:

1. across the UAMS campus (e.g., College Deans, Center Directors, Program Directors);
2. surrounding clinics;
3. American Sign Language interpreter education at the University of Arkansas at Little Rock (Program Director)
4. Arkansas School for the Deaf (Superintendent and/or Assistant to the Superintendent); and
5. Communications Plus+ Interpreter Services, Inc. (owner and operator)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All Subjects; 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.

Device: FaceView Mask™; transparent surgical N95 respirator designed to improve communication; Device: conventional surgical N95 respirator; standard N95 respirator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Understanding Another Person	As recorded on the survey; Difficult; Somewhat difficult; Somewhat easy; Easy	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fit of the Mask	As recorded on the survey; Extremely small; Slightly too small; Fits well; Slightly too large; Extremely large	1 day
Comfort of the Mask	As recorded on the survey; Not comfortable at all; Slightly comfortable; Very comfortable; Extremely comfortable	1 day
Ease of Breathing	As recorded on the survey; Not easy at all; Slightly breathable; Very breathable; Extremely breathable	1 day
Ease of Speaking/Communicating	As recorded on the survey; Difficult; Somewhat difficult; Somewhat easy; Easy	1 day

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Samuel R Atcherson, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: face mask; lip reading
• Other Study ID Numbers: 262478

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No