Product Testing of the FaceView Mask™: Usability Survey

NCT04854694 | Completed Results FDA Device

• 1 other identifier: 262478
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Disability

Keywords

lip reading; face mask

Outcome Measures

Primary Outcomes (1)

• Ease of Understanding Another Person

  As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy

  1 day

Secondary Outcomes (4)

• Fit of the Mask

  1 day

• Comfort of the Mask

  1 day

• Ease of Breathing

  1 day

• Ease of Speaking/Communicating

  1 day

Study Arms (1)

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™; Device: conventional surgical N95 respirator

Interventions

FaceView Mask™ DEVICE

transparent surgical N95 respirator designed to improve communication

All Subjects

conventional surgical N95 respirator DEVICE

standard N95 respirator

All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Results Point of Contact

• Title: Jeanne Hahne, MSN, RN
• Organization: FaceView Mask, LLC

jeannehahne@gmail.com

4155188574

Study Officials

• Samuel R Atcherson, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 22, 2021
• Study Start: November 15, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Locations

US (1)