Assessment of User Preference and Fit of Novel Transparent Face Masks
| Registry | NCT06570161 |
|---|---|
| Status | Withdrawn - funding terminated |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, device feasibility |
| Sponsor | Brigham and Women's Hospital (Other) |
| Conditions | Respiratory Disease, Infection, Coronavirus, Respiratory Tract Infections |
| Interventions | SEEUS95 Transparent mask, CrystalGuard Mask, N95 face mask (Device) |
| Dates | start 2024-10-01 (estimated), primary completion 2025-04-30 (estimated), completion 2025-05-30 (estimated), first posted 2024-08-26, last updated 2025-07-28 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Respiratory Disease All trials for Infection, Coronavirus All trials of SEEUS95 Transparent mask All trials of CrystalGuard Mask
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SEEUS95 | Experimental | Device: SEEUS95 Transparent mask | Transparent mask developed by SEEUS95 |
| CrystalGuard | Experimental | Device: CrystalGuard Mask | Transparent mask developed at BWH |
| N95 | Active comparator | Device: N95 face mask | Standard N95 face mask |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts | United States |