Assessment of Fit of Novel N95 Style Transparent Face Masks

Not Applicable

Not yet recruiting

• Conditions: Infection, Coronavirus; Respiratory Tract Infections; Respiratory Disease
• Interventions: Device: SEEUS95 Transparent mask; Device: N95 face mask; Device: CrystalGuard Mask

• Registration Number: NCT06570161
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-10-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SEEUS95	SEEUS95 Transparent mask	Transparent mask developed by SEEUS95
N95	N95 face mask	Standard N95 face mask
CrystalGuard	CrystalGuard Mask	Transparent mask developed at BWH

Primary Outcome Measures

Name	Time	Method
Acceptability	immediately after mask wearing	User acceptability and comfort wearing the assigned mask graded on a likert scale

Secondary Outcome Measures

Name	Time	Method
Mask preference	immediately after completion of all three arms	Discrete choice of SEEUS-95, CrystalGuard versus standard N-95 mask selected by study participants

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States