Clinical trial NCT04854694: Product Testing of the FaceView Mask™: Usability Survey
Official title: Product Testing of the FaceView Mask™: Usability Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Disability
Keywords: lip reading
face mask
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

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)

Primary outcomes:
measure: Ease of Understanding Another Person
timeFrame: 1 day
Secondary outcomes:
measure: Fit of the Mask
timeFrame: 1 day
measure: Comfort of the Mask
timeFrame: 1 day
measure: Ease of Breathing
timeFrame: 1 day
measure: Ease of Speaking/Communicating
timeFrame: 1 day
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Samuel R Atcherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: