Assessment of Fit of Novel N95 Style Transparent Face Masks

Assessment of User Preference and Fit of Novel Transparent Face Masks

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Tract Infections; Respiratory Disease; Infection, Coronavirus
• Intervention / Treatment: Device: SEEUS95 Transparent mask; Device: CrystalGuard Mask; Device: N95 face mask

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEEUS95; Transparent mask developed by SEEUS95	Device: SEEUS95 Transparent mask; SEEUS95 developed transparent filtering mask; Other Names: SEEUS95
Experimental: CrystalGuard; Transparent mask developed at BWH	Device: CrystalGuard Mask; CrystalGuard transparent mask; Other Names: CrystalGuard
Active Comparator: N95; Standard N95 face mask	Device: N95 face mask; Standard N95 style face mask; Other Names: N95

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	User acceptability and comfort wearing the assigned mask graded on a likert scale	immediately after mask wearing

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Peter Chai, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; Infections; Communicable Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Coronavirus Infections; Respiration Disorders
• Other Study ID Numbers: 2024P001913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No