Respiratory DiseaseNCT06570161
Assessment of Fit of Novel N95 Style Transparent Face Masks
A study testing SEEUS95 Transparent mask, CrystalGuard Mask and N95 face mask in people with Respiratory Disease and Infection, Coronavirus, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Infection, Coronavirus, Respiratory Tract Infections
- What is being tested?
- SEEUS95 Transparent mask, CrystalGuard Mask and N95 face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- Less than 18 years old
- Unable to smell Bitrex solution used for fit testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
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.
- Being tested
- SEEUS95 Transparent mask, CrystalGuard Mask, N95 face mask
- Medical subject headings
- Respiration Disorders, Coronavirus Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEEUS95 Transparent maskDevice
Also called SEEUS95
SEEUS95 developed transparent filtering mask
CrystalGuard MaskDevice
Also called CrystalGuard
CrystalGuard transparent mask
N95 face maskDevice
Also called N95
Standard N95 style face mask
| Study group | Role | What they receive |
|---|---|---|
| SEEUS95 | Experimental | Transparent mask developed by SEEUS95 Receives: Device: SEEUS95 Transparent mask |
| CrystalGuard | Experimental | Transparent mask developed at BWH Receives: Device: CrystalGuard Mask |
| N95 | Active comparator | Standard N95 face mask Receives: Device: N95 face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
User acceptability and comfort wearing the assigned mask graded on a likert scale
Measured: immediately after mask wearing
Secondary outcomes (1)
Mask preference
Discrete choice of SEEUS-95, CrystalGuard versus standard N-95 mask selected by study participants
Measured: immediately after completion of all three arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Why it stopped: funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter R Chai MD, Brigham and Women's Hospital
- Investigators
- Peter Chai, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570161
- Sponsor's protocol ID
- 2024P001913
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of User Preference and Fit of Novel Transparent Face Masks
- ClinicalTrials.gov ID
- NCT06570161
- Acronym / sponsor ID
- 2024P001913
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| SEEUS95 | Experimental | Device: SEEUS95 Transparent maskTransparent mask developed by SEEUS95 |
| CrystalGuard | Experimental | Device: CrystalGuard MaskTransparent mask developed at BWH |
| N95 | Active comparator | Device: N95 face maskStandard N95 face mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (2 listed)
- Less than 18 years old
- Unable to smell Bitrex solution used for fit testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEEUS95 Transparent maskAlso: SEEUS95SEEUS95 developed transparent filtering mask | Device | SEEUS95 |
| CrystalGuard MaskAlso: CrystalGuardCrystalGuard transparent mask | Device | CrystalGuard |
| N95 face maskAlso: N95Standard N95 style face mask | Device | N95 |
Primary outcome
Acceptability
Time frame: immediately after mask wearing
User acceptability and comfort wearing the assigned mask graded on a likert scale
1 secondary outcome
Mask preference
Time frame: immediately after completion of all three arms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Chai, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEEUS95 Transparent mask, CrystalGuard Mask and N95 face mask in people with Respiratory Disease and Infection, Coronavirus, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: immediately after mask wearing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.