Assessment of Fit of Novel N95 Style Transparent Face Masks

NCT06570161 | Withdrawn

• 1 other identifier: 2024P001913
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease; Infection, Coronavirus; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Acceptability

  User acceptability and comfort wearing the assigned mask graded on a likert scale

  immediately after mask wearing

Secondary Outcomes (1)

• Mask preference

  immediately after completion of all three arms

Study Arms (3)

SEEUS95

EXPERIMENTAL

Transparent mask developed by SEEUS95

Device: SEEUS95 Transparent mask

CrystalGuard

EXPERIMENTAL

Transparent mask developed at BWH

Device: CrystalGuard Mask

N95

ACTIVE COMPARATOR

Standard N95 face mask

Device: N95 face mask

Interventions

SEEUS95 Transparent mask DEVICE

SEEUS95 developed transparent filtering mask

Also known as: SEEUS95

SEEUS95

CrystalGuard Mask DEVICE

CrystalGuard transparent mask

Also known as: CrystalGuard

CrystalGuard

N95 face mask DEVICE

Standard N95 style face mask

Also known as: N95

N95

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• Less than 18 years old
• Unable to smell Bitrex solution used for fit testing

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Respiration Disorders; Coronavirus Infections; Respiratory Tract Infections

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Peter Chai, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized crossover design

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)