Infection, Coronavirus, Respiratory Disease, Respiratory Tract Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESEEUS95 Transparent mask
SEEUS95 developed transparent filtering mask
DEVICECrystalGuard Mask
CrystalGuard transparent mask
DEVICEN95 face mask
Standard N95 style face mask
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Randomized crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \>18 years old * No history of asthma, restrictive lung disease, interstitial lung disease, or emphysema * Lack of significant facial hair that precludes wearing a N-95 mask
Exclusion criteria
* Less than 18 years old * Unable to smell Bitrex solution used for fit testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | immediately after mask wearing | User acceptability and comfort wearing the assigned mask graded on a likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mask preference | immediately after completion of all three arms | Discrete choice of SEEUS-95, CrystalGuard versus standard N-95 mask selected by study participants |
Countries
United States
Outcome results
None listed