Transparent Face Masks for Respiratory Protection

Overseen By Peter Chai, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Asthma, Emphysema, Facial hair, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new transparent face masks, SEEUS95 and CrystalGuard, which aim to protect against respiratory pathogens while allowing facial expressions to be seen. These masks are designed to improve communication, especially for those who rely on lip-reading or facial cues. The trial compares these new masks with standard N95 masks to evaluate their effectiveness and comfort. Suitable participants have no history of lung diseases, such as asthma, and do not have heavy facial hair that could interfere with mask fitting. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for enhanced communication and protection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these transparent face masks are safe for respiratory protection?

Research shows that transparent face masks like the CrystalGuard and SEEUS95 are designed to function like N95 masks. These masks aim to protect against germs while allowing visibility of facial expressions.

Specific safety data for these new transparent masks is not yet available. However, studies on similar masks suggest they are generally well-tolerated. The SEEUS95 mask, for instance, claims to filter out 95% of particles, blocking most particles while remaining comfortable to wear.

The CrystalGuard mask is reusable and fits better than many regular surgical masks, potentially offering improved safety in terms of fit and comfort. Given their similarity to the widely trusted N95 masks, these masks are likely safe for most people.

In summary, although direct safety data for these masks is lacking, their design and resemblance to N95 masks suggest they should be safe and comfortable to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these transparent face masks because they offer a new way to protect against respiratory threats while maintaining visibility of facial expressions. While standard N95 masks are effective for protection, they can obscure communication, especially in environments where seeing facial expressions is crucial. The CrystalGuard Mask, developed at Brigham and Women's Hospital, and the SEEUS95 transparent mask, both serve the dual purpose of protection and clear communication. Their transparent design allows for better interaction without compromising safety, which is a game-changer in settings like healthcare and education where clear communication is essential.

What evidence suggests that these transparent face masks are effective for respiratory protection?

This trial will compare the effectiveness of transparent masks, CrystalGuard and SEEUS95, with standard N95 masks. Studies have shown that clear masks like CrystalGuard and SEEUS95 offer protection against germs similar to traditional N95 masks. Participants may receive the CrystalGuard mask, which is affordable and fits better than regular surgical masks. It adheres to the face using medical adhesive, preventing air leaks and fogging. Alternatively, participants may receive the SEEUS95 mask, which claims to protect better than many popular cloth or plastic masks. It is designed to adhere to the face independently, potentially increasing comfort and effectiveness. These masks aim to ensure safety while allowing visibility of facial expressions, which is important for communication. ^{2 3 4 6 7}

Who Is on the Research Team?

Peter Chai, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who are interested in testing the feasibility and acceptability of two new transparent face masks designed to protect against respiratory pathogens like COVID-19. Specific eligibility criteria were not provided.

Inclusion Criteria

I am over 18 years old.

Lack of significant facial hair that precludes wearing a N-95 mask

I have never had asthma or serious lung diseases.

Exclusion Criteria

I am under 18 years old.

Unable to smell Bitrex solution used for fit testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Study Visit

Participants are randomized to wear each of the three masks (SEEUS-95, CrystalGuard, N95) and undergo FIT testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for feedback on mask comfort and preference

1 week

What Are the Treatments Tested in This Trial?

Interventions

• CrystalGuard Mask
• SEEUS95 Transparent mask

Trial Overview The study is comparing the traditional N95 face mask with two novel transparent masks: CrystalGuard Mask and SEEUS95 Transparent mask, to assess their effectiveness and user experience.

How Is the Trial Designed?

Group I: SEEUS95 Experimental Treatment 1 Intervention

Transparent mask developed by SEEUS95

Group II: CrystalGuard Experimental Treatment 1 Intervention

Transparent mask developed at BWH

Group III: N95 Active Control 1 Intervention

Standard N95 face mask

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

A modified strapless surgical mask design significantly improved aerosol protection compared to standard loose-fitting surgical masks, achieving a median fit factor of 53.8, which indicates much lower inward leakage of aerosols (1.79%) compared to 29.5% for loose-fitting masks.

The sealed surgical mask provided better breathability and comfort than N95 FFRs, with participants rating it 9 out of 10 for both, suggesting it could be a viable alternative for healthcare workers during N95 shortages, although individual mask evaluations are still recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fit for Sealed and Loose-Fitting Surgical Masks and N95 Filtering Facepiece Respirators. Karuppasamy, K., Obuchowski, N.[2021]

Citations

1. drive.hhs.gov drive.hhs.gov/mask2_winners.html

Mask Innovation Challenge - BARDA DRIVe - HHS.gov Description: The CrystalGuard clear mask is reusable, cost-effective, and better-fitting when compared with widely available surgical masks. Therefore, it has ...

2. withpower.com withpower.com/trial/phase-respiration-disorders-9-2024-c4922

Transparent Face Masks for Respiratory Protection There is no specific safety data available for transparent face masks like CrystalGuard Mask or SEEUS95 Transparent mask, but a study on a similar face mask ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06570161?cond=Coronavirus&aggFilters=status:not&viewType=Table&rank=5

Assessment of Fit of Novel N95 Style Transparent Face ... 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 ...

4. scientificamerican.com scientificamerican.com/article/better-face-masks-are-possible-here-are-some-winning-designs/

Better Face Masks Are Possible: Here Are Some Winning ... The five new finalists include three transparent or semi-transparent designs: ClearMask, CrystalGuard and Matregenix Mask. There is also the ...

5. mdedge.com mdedge.com/idpractitioner/article/256243/infectious-diseases/coming-soon-more-breathable-more-comfortable-face

Coming soon: More breathable, more comfortable face ... The mask's medical adhesive sticks directly to the face, without causing breakouts, he said. It doesn't let air leak and won't fog his glasses.

6. supershieldglobal.com supershieldglobal.com/tech_document/sds_crystalguard.pdf

Supershield Crystalguard Supershield Crystalguard. 1.2. RECOMMENDED USE. SAFETY DATA SHEET. SUPERSHIELD CRYSTALGUARD. Waterproofing and protection of concrete. 1.3. COMPANY DETAILS. 1.4.

7. cpchem.com cpchem.com/sites/default/files/2024-12/02132144.pdf

Nose Guard® Masking Agent Show this material safety data sheet to the doctor in attendance. Material may produce a serious, potentially fatal pneumonia if swallowed or ...