Product Testing of the FaceView Mask™: Usability Survey

Study Overview
=================
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.

Official Title
-----------------
Product Testing of the FaceView Mask™: Usability Survey

Conditions
-----------------
Hearing Disability

Intervention / Treatment
-----------------
* Device: FaceView Mask™
* Device: conventional surgical N95 respirator


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will try on both the FaceView Mask™ and the conventional surgical N95 respirator in quasi-random order from participant to participant and provide feedback via survey afterward.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Subjects<br>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™<br>* transparent surgical N95 respirator designed to improve communication<br>Device: conventional surgical N95 respirator<br>* standard N95 respirator<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lip reading, face mask