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WithdrawnNCT06570161Updated Jul 28, 2025

Assessment of Fit of Novel N95 Style Transparent Face Masks

An interventional study of SEEUS95 Transparent mask and CrystalGuard Mask in Respiratory Disease, Infection, Coronavirus and Respiratory Tract Infections, sponsored by Brigham and Women's Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Device feasibility

Why this study was withdrawn
funding terminated
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Disease
  • Infection, Coronavirus
  • Respiratory Tract Infections
03

In context

Respiration Disorders

512 studies on the registry are indexed under Respiration Disorders; 98 are open to participants now.

Browse Respiration Disorders studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Less than 18 years old
  • Unable to smell Bitrex solution used for fit testing
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    SEEUS95

    Transparent mask developed by SEEUS95

    Device: SEEUS95 Transparent mask

  • Experimental
    CrystalGuard

    Transparent mask developed at BWH

    Device: CrystalGuard Mask

  • Active comparator
    N95

    Standard N95 face mask

    Device: N95 face mask

Interventions

  • DeviceSEEUS95 Transparent mask

    SEEUS95 developed transparent filtering mask

    Also known as: SEEUS95

  • DeviceCrystalGuard Mask

    CrystalGuard transparent mask

    Also known as: CrystalGuard

  • DeviceN95 face mask

    Standard N95 style face mask

    Also known as: N95

06

What researchers measure

Primary outcomes

  1. Acceptability

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

    Time frame: immediately after mask wearing

Secondary outcomes

  1. Mask preference

    Discrete choice of SEEUS-95, CrystalGuard versus standard N-95 mask selected by study participants

    Time frame: immediately after completion of all three arms

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06570161
Lead sponsor
Brigham and Women's Hospital
Responsible party
Peter R Chai MD (Associate Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Aug 26, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Jul 28, 2025

Study contacts

Peter Chai, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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