Product Testing of the FaceView Mask™: Usability Survey

Hearing Disability Clinical Trial

Official title:

Product Testing of the FaceView Mask™: Usability Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854694
• Other study ID #: 262478
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: February 9, 2024

Study information

• Verified date: February 2024
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 9, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hearing Disability

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ease of understanding another person	As recorded on the survey; Difficult; Somewhat difficult; Somewhat easy; Easy	1 day
Secondary	fit of the mask	As recorded on the survey; Extremely small; Slightly too small; Fits well; Slightly too large; Extremely large	1 day
Secondary	comfort of the mask	As recorded on the survey; Not comfortable at all; Slightly comfortable; Very comfortable; Extremely comfortable	1 day
Secondary	ease of breathing	As recorded on the survey; Not easy at all; Slightly breathable; Very breathable; Extremely breathable	1 day
Secondary	ease of speaking/communicating	As recorded on the survey; Difficult; Somewhat difficult; Somewhat easy; Easy	1 day