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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FaceView Mask™ | Device | transparent surgical N95 respirator designed to improve communication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Understanding Another Person | As recorded on the survey
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Fit of the Mask | As recorded on the survey
| 1 day |
| Comfort of the Mask | As recorded on the survey
|
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel R Atcherson, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transparent Mask First, Then Non-Transparent Mask | Participants completed fit testing protocol using the transparent mask first, followed by the same fit testing protocol with a non-transparent mask, then completed a questionnaire. |
| FG001 | Non-Transparent Mask First, Then Transparent Mask | Participants completed fit testing protocol using the non-transparent mask first, followed by the same fit testing protocol with a transparent mask, then completed a questionnaire. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ease of Understanding Another Person | As recorded on the survey
| Posted | Count of Participants | Participants | 1 day |
|
|
1 day
Exclusionary criteria were provided and the masks evaluated were not in a clinical environment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transparent Mask | Wore FaceView Mask which is the transparent mask | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeanne Hahne, MSN, RN | FaceView Mask, LLC | 4155188574 | jeannehahne@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2023 | Feb 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2023 | Mar 7, 2025 | SAP_002.pdf |
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| conventional surgical N95 respirator | Device | standard N95 respirator |
|
| 1 day |
| Ease of Breathing | As recorded on the survey
| 1 day |
| Ease of Speaking/Communicating | As recorded on the survey
| 1 day |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex/Gender, Customized | Female, Male, Intersex, Prefer Not to Say | Count of Participants | Participants |
|
| Sex: Female, Male | At the outset of the study, we permitted participants to select male, female, intersex, or prefer not to say. | One participant identified as Intersex | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Fit of the Mask | As recorded on the survey
| Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Comfort of the Mask | As recorded on the survey
| Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Ease of Breathing | As recorded on the survey
| Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Ease of Speaking/Communicating | As recorded on the survey
| Posted | Count of Participants | Participants | 1 day |
|
|
|
| 202 |
| 0 |
| 202 |
| 0 |
| 202 |
| EG001 | Non-Transparent Mask | Wore 3M N95 mask which is the non-transparent mask | 0 | 202 | 0 | 202 | 0 | 202 |
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| Fits well |
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| Slightly too large |
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| Extremely large |
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| Very comfortable |
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| Extremely comfortable |
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| Very breathable |
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| Extremely breathable |
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| Somewhat easy |
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| Easy |
|