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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment CrystalGuard Mask, SEEUS95 Transparent mask?

The study on the use of plastic tape to seal N-95 masks showed that sealing can significantly improve the fit and reduce leaks, which suggests that similar sealing techniques or materials used in transparent masks like CrystalGuard could enhance their effectiveness in providing respiratory protection. ^{1 2 3 4 5}

Is the use of transparent face masks generally safe for humans?

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 with a personalized sealing device showed it could provide effective protection without reported safety issues. However, a case of contact urticaria (skin rash) was reported with a different type of protective mask, suggesting that some individuals might experience allergic reactions to certain mask materials. ^{6 7 8 9 10}

How is the CrystalGuard Mask treatment different from other treatments for respiratory protection?

The CrystalGuard Mask and SEEUS95 Transparent mask are unique because they are transparent, allowing for better facial visibility and communication compared to traditional opaque masks, which can be important in settings where seeing facial expressions is crucial. ^{11 12 13 14 15}

Research Team

Peter Chai, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Utilization of a mask fitter or micropore tape to improve the fit of a surgical mask. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Visual consideration and correction for respiratory protective masks. [2004]

3. England pubmed.ncbi.nlm.nih.gov

The application of a surgical face mask over different oxygen delivery devices; a crossover study of measured end-tidal oxygen concentrations. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of plastic tape seal to reduce face seal leak in respirator N-95 type 1860. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cephalic versus oronasal mask for noninvasive ventilation in acute hypercapnic respiratory failure. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Study of the use of a personalized peripheral sealing device on surgical face masks in high-risk situations against COVID-19. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Antimicrobial Face Shield: Next Generation of Facial Protective Equipment against SARS-CoV-2 and Multidrug-Resistant Bacteria. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Contact urticaria to the M17 protective mask. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of Fit for Sealed and Loose-Fitting Surgical Masks and N95 Filtering Facepiece Respirators. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of Taping The Upper Mask Edge On Ocular Surface Stability and Dry Eye Symptoms. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Color properties of artificial white spot lesions treated by experimental resin infiltrants containing bioactive glass and nano-fluorohydroxyapatite. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Study of the radio-opacity of base and liner dental materials using a digital radiography system. [2022]

13. India pubmed.ncbi.nlm.nih.gov

Fluoride release and fluoride-recharging ability of three different sealants. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

2-year clinical performance of a resin-modified glass ionomer sealant. [2013]

15. United States pubmed.ncbi.nlm.nih.gov

Effect of a triclosan/copolymer pre-brush mouthrinse on established plaque formation and gingivitis: a six-month clinical study in Thailand. [2013]