Assessment of Fit of Novel N95 Style Transparent Face Masks

Mass General Brigham

Status: Not yet enrolling

Conditions: Respiratory Disease; Infection, Coronavirus; Respiratory Tract Infections

Treatments: Device: CrystalGuard Mask; Device: SEEUS95 Transparent mask; Device: N95 face mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06570161

2024P001913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

SEEUS95

Experimental group

Description:

Transparent mask developed by SEEUS95

Treatment:

Device: SEEUS95 Transparent mask

CrystalGuard

Experimental group

Description:

Transparent mask developed at BWH

Treatment:

Device: CrystalGuard Mask

N95

Active Comparator group

Description:

Standard N95 face mask

Treatment:

Device: N95 face mask