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Face masks have become a critically important public health intervention after the COVID-19 pandemic. Multiple types of masks ranging from full face filtering to cloth masks have been developed and commercialized to facilitate protection against respiratory pathogens. Most of these systems are made with opaque fabrics and may prevent individuals from expressing emotions or for those who are deaf and hard of hearing, communicating. To date, few transparent face masks which also confer respiratory pathogen protection have been developed. This study will test the feasability and acceptability of two new masks, the SEEUS-95 mask and CrystalGuard mask which are both transparent versions of N-95 filtering face masks.
This is a randomized crossover trial to evaluate the feasibility, acceptability and choice between the use of the SEEUS-95, CrystalGuard transparent face masks or a standard N95 mask. Otherwise healthy individuals will be prescreened and then scheduled for a single study visit. Participants will be randomized to wear each of the three masks (SEEUS-95, CrystalGuard, N95). They will be taught how to wear the mask, and we will assist participants with correctly wearing the mask for a good fit. Next, participants will undergo standard FIT testing where a clear hood will be placed over the participant's head, and a bitter solution (Bitrex) is sprayed into the hood. A positive test is indicated if the participant is able to taste Bitrex demonstrating that there is a detected leak within the mask. After a few minute washout period, participants will undergo FIT testing of subsequent masks. We will ask participants to rate the comfort of wearing the masks, willingness to wear masks in public and suggestions for improvement in mask design. Finally, we will conduct a discrete choice test to ask participants which mask they would prefer to wear in public.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEEUS95 | Experimental | Transparent mask developed by SEEUS95 |
|
| CrystalGuard | Experimental | Transparent mask developed at BWH |
|
| N95 | Active Comparator | Standard N95 face mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEEUS95 Transparent mask | Device | SEEUS95 developed transparent filtering mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | User acceptability and comfort wearing the assigned mask graded on a likert scale | immediately after mask wearing |
| Measure | Description | Time Frame |
|---|---|---|
| Mask preference | Discrete choice of SEEUS-95, CrystalGuard versus standard N-95 mask selected by study participants | immediately after completion of all three arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Chai, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D018352 | Coronavirus Infections |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000087162 | N95 Respirators |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D012134 | Respiratory Protective Devices |
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Randomized crossover design
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| CrystalGuard Mask | Device | CrystalGuard transparent mask |
|
|
| N95 face mask | Device | Standard N95 style face mask |
|
|
| D014777 | Virus Diseases |
| D007239 | Infections |
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |