NCT06570161

Assessment of Fit of Novel N95 Style Transparent Face Masks

Assessment of User Preference and Fit of Novel Transparent Face Masks

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Disease
• Infection, Coronavirus
• Respiratory Tract Infections

Interventions

Type	Name	Description
DEVICE	SEEUS95 Transparent mask	SEEUS95 developed transparent filtering mask
DEVICE	CrystalGuard Mask	CrystalGuard transparent mask
DEVICE	N95 face mask	Standard N95 style face mask

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-04-30
• Completion: 2025-05-30
• First posted: 2024-08-26
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States