Hearing Disability
Conditions
Keywords
lip reading, face mask
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.
Interventions
DEVICEFaceView Mask™
transparent surgical N95 respirator designed to improve communication
DEVICEconventional surgical N95 respirator
standard N95 respirator
Sponsors
University of Arkansas
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Understanding Another Person | 1 day | As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fit of the Mask | 1 day | As recorded on the survey 1. Extremely small 2. Slightly too small 3. Fits well 4. Slightly too large 5. Extremely large |
| Comfort of the Mask | 1 day | As recorded on the survey 1. Not comfortable at all 2. Slightly comfortable 3. Very comfortable 4. Extremely comfortable |
| Ease of Breathing | 1 day | As recorded on the survey 1. Not easy at all 2. Slightly breathable 3. Very breathable 4. Extremely breathable |
| Ease of Speaking/Communicating | 1 day | As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
FaceView Mask™: transparent surgical N95 respirator designed to improve communication
conventional surgical N95 respirator: standard N95 respirator | 202 |
| Total | 202 |
Baseline characteristics
| Characteristic | All Subjects | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 198 Participants | — |
| Age, Continuous | 34.3 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 173 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
| Sex/Gender, Customized Female | 173 Participants | — |
| Sex/Gender, Customized Intersex | 1 Participants | — |
| Sex/Gender, Customized Male | 28 Participants | — |
| Sex/Gender, Customized Prefer Not to Say | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 202 | 0 / 202 |
| other Total, other adverse events | 0 / 202 | 0 / 202 |
| serious Total, serious adverse events | 0 / 202 | 0 / 202 |
Outcome results
Primary
Ease of Understanding Another Person
As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transparent Mask | Ease of Understanding Another Person | Difficult | 0 Participants |
| Transparent Mask | Ease of Understanding Another Person | Somewhat difficult | 4 Participants |
| Transparent Mask | Ease of Understanding Another Person | Somewhat easy | 36 Participants |
| Transparent Mask | Ease of Understanding Another Person | Easy | 162 Participants |
| Non-Transparent Mask | Ease of Understanding Another Person | Easy | 64 Participants |
| Non-Transparent Mask | Ease of Understanding Another Person | Difficult | 24 Participants |
| Non-Transparent Mask | Ease of Understanding Another Person | Somewhat easy | 47 Participants |
| Non-Transparent Mask | Ease of Understanding Another Person | Somewhat difficult | 67 Participants |
Secondary
Comfort of the Mask
As recorded on the survey 1. Not comfortable at all 2. Slightly comfortable 3. Very comfortable 4. Extremely comfortable
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transparent Mask | Comfort of the Mask | Not comfortable at all | 2 Participants |
| Transparent Mask | Comfort of the Mask | Slightly comfortable | 46 Participants |
| Transparent Mask | Comfort of the Mask | Very comfortable | 115 Participants |
| Transparent Mask | Comfort of the Mask | Extremely comfortable | 39 Participants |
| Non-Transparent Mask | Comfort of the Mask | Extremely comfortable | 8 Participants |
| Non-Transparent Mask | Comfort of the Mask | Not comfortable at all | 31 Participants |
| Non-Transparent Mask | Comfort of the Mask | Very comfortable | 53 Participants |
| Non-Transparent Mask | Comfort of the Mask | Slightly comfortable | 110 Participants |
Secondary
Ease of Breathing
As recorded on the survey 1. Not easy at all 2. Slightly breathable 3. Very breathable 4. Extremely breathable
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transparent Mask | Ease of Breathing | Very breathable | 123 Participants |
| Transparent Mask | Ease of Breathing | Not easy at all | 1 Participants |
| Transparent Mask | Ease of Breathing | Extremely breathable | 47 Participants |
| Transparent Mask | Ease of Breathing | Slightly breathable | 31 Participants |
| Non-Transparent Mask | Ease of Breathing | Extremely breathable | 11 Participants |
| Non-Transparent Mask | Ease of Breathing | Slightly breathable | 85 Participants |
| Non-Transparent Mask | Ease of Breathing | Very breathable | 81 Participants |
| Non-Transparent Mask | Ease of Breathing | Not easy at all | 25 Participants |
Secondary
Ease of Speaking/Communicating
As recorded on the survey 1. Difficult 2. Somewhat difficult 3. Somewhat easy 4. Easy
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transparent Mask | Ease of Speaking/Communicating | Difficult | 0 Participants |
| Transparent Mask | Ease of Speaking/Communicating | Somewhat easy | 36 Participants |
| Transparent Mask | Ease of Speaking/Communicating | Somewhat difficult | 9 Participants |
| Transparent Mask | Ease of Speaking/Communicating | Easy | 157 Participants |
| Non-Transparent Mask | Ease of Speaking/Communicating | Easy | 54 Participants |
| Non-Transparent Mask | Ease of Speaking/Communicating | Difficult | 20 Participants |
| Non-Transparent Mask | Ease of Speaking/Communicating | Somewhat difficult | 64 Participants |
| Non-Transparent Mask | Ease of Speaking/Communicating | Somewhat easy | 64 Participants |
Secondary
Fit of the Mask
As recorded on the survey 1. Extremely small 2. Slightly too small 3. Fits well 4. Slightly too large 5. Extremely large
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transparent Mask | Fit of the Mask | Slightly too small | 7 Participants |
| Transparent Mask | Fit of the Mask | Slightly too large | 21 Participants |
| Transparent Mask | Fit of the Mask | Fits well | 172 Participants |
| Transparent Mask | Fit of the Mask | Extremely large | 0 Participants |
| Transparent Mask | Fit of the Mask | Extremely small | 2 Participants |
| Non-Transparent Mask | Fit of the Mask | Extremely large | 0 Participants |
| Non-Transparent Mask | Fit of the Mask | Extremely small | 4 Participants |
| Non-Transparent Mask | Fit of the Mask | Slightly too small | 29 Participants |
| Non-Transparent Mask | Fit of the Mask | Fits well | 142 Participants |
| Non-Transparent Mask | Fit of the Mask | Slightly too large | 27 Participants |