Mask Fit Testing for Healthy Subjects

Not currently recruiting at 1 trial location

Overseen By Patrice Ratliffe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnancy, Respiratory illness, Allergies, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate mask fit by examining face measurements and self-assessments of face size and shape. It seeks to determine if individuals can accurately measure their facial dimensions and select the appropriate mask for protection against airborne particles. Group A will try on masks in a controlled environment to assess their effectiveness in blocking small particles, while Group B will have their faces measured and complete a survey. Healthy individuals without facial hair who are comfortable in small spaces may be suitable for Group A. As an unphased trial, this study allows participants to contribute to important research on mask effectiveness without the risks associated with drug trials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is focused on mask fit testing and involves healthy participants, it is unlikely that you will need to change your medication routine.

What prior data suggests that this mask fit testing is safe for participants?

Research shows that mask fit testing, like the kind used in this study, reliably checks how well masks protect users. For KN95 masks, studies confirm that fit testing ensures the mask seals properly to the face, which is crucial for protection. However, about 69% of masks might not pass the test on the first try, highlighting the importance of finding the right fit.

Similarly, fit testing for surgical masks ensures comfort and the expected level of protection. Both types of masks undergo similar tests to check fit and protection. The process involves wearing the mask and moving the head in specific ways to see if the mask stays snug.

Overall, these fit testing processes are safe. They are routine and widely used to ensure masks perform their protective function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of fit testing for two types of masks, KN95 and surgical/procedure masks. Unlike traditional mask-wearing methods, this trial uses a modified version of the OSHA fit test, aiming to improve mask fit and thus, potentially enhance protection against airborne particles. By modifying the fit with a clip behind the neck, the trial looks to assess whether this adjustment can provide a more secure and comfortable fit. Understanding these nuances could lead to better guidelines for mask usage, especially in health-related settings where optimal protection is crucial.

What evidence suggests that this study's mask fit testing methods are effective for assessing protection against aerosol contaminants?

Research shows that a mask's fit directly affects its ability to protect against germs. In this trial, participants will undergo fit testing for both KN95 masks and surgical masks. One study found that about 79% of KN95 masks fit well enough to provide good protection. Another study demonstrated that wearing masks, including KN95s, indoors reduced the chances of contracting COVID-19. Surgical masks had a lower fit rate of about 32%, indicating they might not fit as well as KN95s. However, consistently wearing any mask indoors was associated with a lower risk of testing positive for COVID-19. Proper fit testing, as conducted in this trial, is crucial to ensure masks work effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

James Samet, PhD

Principal Investigator

U.S. Environmental Protection Agency

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18-70, of any gender. Participants will be asked to self-assess their facial dimensions and undergo face measurements using anthropological techniques and a 3D camera.

Inclusion Criteria

I consider myself to be in good health.

I can walk and am okay with being in small, enclosed spaces.

Subjects must pass COVID-19 screening questions and have had at least a primary COVID-19 vaccination series

Exclusion Criteria

Individuals who have active allergies

Anyone who has been hospitalized overnight or sought urgent medical care in the last 30 days

I do not have any health conditions that could make this study risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Consent and Initial Assessment

Participants provide informed consent and complete initial assessments including a behavioral questionnaire and craniofacial measurements

1 day

1 visit (in-person)

Mask Fit Testing

Participants undergo mask fit testing using aerosolized sodium chloride particles to measure fitted filtration efficiency

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post mask fit testing

1 day

What Are the Treatments Tested in This Trial?

Interventions

• KN95 Mask Fit testing
• Surgical/Procedure Mask Fit Testing

Trial Overview

The study aims to determine how well common masks like KN95s and surgical masks fit based on the size and shape of a person's face. It involves comparing self-evaluation methods against standard measurement techniques in a controlled environment with aerosolized particles.

How Is the Trial Designed?

Group I: Mask Testing Experimental Treatment 2 Interventions

All participants will be fit tested while completing a modified version of the OSHA fit test. The subject will remain seated in the chamber and complete a modified version the Occupational Safety and Health Administration Quantitative Fit Testing Protocol (Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for Filtering Facepiece TableA-2-RESPIRATORS). The subject will then move their head from left to right, taking two breaths at each extreme for 30 seconds. This will be followed by moving the head up and down, taking two beaths at each extreme for 30 seconds. The procedure will be repeated after the addition of a clip to the ear-loops of the mask behind the neck of the subject. In total, the testing time for the 2 masks with and without clip will be approximately 6 minutes.

Group II: Craniometric and Behavioral Assessment Active Control 1 Intervention

First, the subjects height and weight will be measured using standard methods (scale and stadiometer). They will be asked to remove their shoes and empty their pockets before being weighed. Four to eight face, head, and neck features will also be measured using spreading and sliding calipers and a measuring tape. Trained personnel (wearing gloves) will palpate the subjects face and to ensure proper caliper measurements are collected. Cosmetic pencils will be used to identify landmarks on the face and neck in order assist in the measurement of craniofacial features. Following facial measurements, a study team member will take a 3D picture of the subject's face using a camera. The image takes approximately 10 seconds to generate. We will first position the subject in from of the camera and ask them to tighten any loose hair so we can have a clear view of their ears. It is recommended that subjects wear a non-collared shirt, preferably a t-shirt. If they wea

KN95 Mask Fit testing is already approved in China, European Union, United States for the following indications:

Approved in China as KN95 Respirator for:

• Protection against airborne pathogens
• Prevention of respiratory infections

Approved in European Union as FFP2 Mask for:

• Protection against airborne pathogens
• Prevention of respiratory infections

Approved in United States as KN95 Respirator for:

• Emergency Use Authorization for protection against COVID-19

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Environmental Protection Agency (EPA)

Collaborator

Trials

40

Recruited

95,500+

Published Research Related to This Trial

Several NIOSH-approved N95 filtering facepiece respirators (FFRs) demonstrated strong resistance to synthetic blood penetration, indicating their potential safety for use in healthcare settings during procedures involving body fluids.

The study suggests that incorporating FDA clearance requirements into the NIOSH approval process could increase the availability of effective surgical N95 FFRs, which is crucial during times of respirator shortages, such as a pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators. Rengasamy, S., Sbarra, D., Nwoko, J., et al.[2022]

Fluid Resistant Surgical Masks do not provide protection against inhaled smoke particles, indicating they may be inadequate for respiratory protection in healthcare settings.

FFP3 masks offer complete protection but require proper fit to avoid facial trauma, suggesting a need for improved fit testing and daily checks for healthcare workers using these masks, especially in areas with COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19: smoke testing of surgical mask and respirators. Douglas, JDM., McLean, N., Horsley, C., et al.[2021]

In a study involving 180 fit-tests of nine types of FFP2 respirator masks across three hospitals, only 27% of the tests were successful, indicating that many masks did not fit properly for healthcare workers.

Flat-fold respirator masks had a significantly higher success rate (57.5%) compared to duckbill (18.3%) and hard shell masks (3.3%), suggesting that mask design plays a crucial role in ensuring effective respiratory protection for healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of respirator masks for healthcare workers, in France. Ciotti, C., Pellissier, G., Rabaud, C., et al.[2019]

FFP2/KN95 respirators show significant variability in their protective capabilities, highlighting the importance of proper fit testing for effective use.

Healthcare workers at risk for airborne diseases, such as COVID-19, influenza, or tuberculosis, should undergo fit testing to ensure optimal protection from these pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respirators evaluated by fit testing. Kleinjohann, L., Lange, C.[2020]

The pilot trial focused on testing the fit of N95 respirator masks in a metropolitan general practice setting, highlighting the importance of proper mask fit for effective respiratory protection.

The study also examined how failures in mask fit testing were addressed, which is crucial for ensuring that healthcare workers are adequately protected against airborne pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative respirator fit tests for P2/N95 in Australian general practice. Chapman, D., Chapman, L., Ganesan, A.[2022]

In a study involving 100 participants, 13% failed fit testing when wearing a procedural mask over an N95 respirator, indicating that this combination may compromise the respirator's effectiveness.

The findings suggest that while N95 respirators are designed for high filtration efficiency, adding an overlying mask can negatively impact their fit and protective capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two masks can be worse than one: N95 respirator failure caused by an overlying face mask. Mueller, JT., Geyer, HD., Karimi, S., et al.[2023]

Combining a surgical mask with a highly efficient FFP respirator significantly enhances respiratory protection for healthcare workers, achieving a protection factor over 200, which is well above the minimum required level of 100.

The study utilized fit testing on healthcare workers in various breathing situations to quantify the effectiveness of different FFP respirators and their combinations with surgical masks, demonstrating that this combination improves fit and filtration efficiency against SARS-CoV-2 exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of the Adjustment of Self-Filtering Masks in Combination with Surgical Masks for the Protection of Health Professionals in the Care of Patients Affected by SARS-COV-2 from an Experimental Study]. García Vela, R., Cabanas Valdés, R., Huertas Ríos, S., et al.[2021]

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]

In a study involving 78 physicians, FFP3 filtering respirators demonstrated a significantly higher fit factor compared to commonly used surgical masks, indicating better protection against airborne particles (P<0.001).

Despite the superior fit of FFP3 masks, 97% of participants still preferred using surgical masks in clinical settings, highlighting a gap between safety and practice in infection control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit factor of masks used by Physicians in Clinical Settings. De-Yñigo-Mojado, B., Madera-García, J., Becerro-de-Bengoa-Vallejo, R., et al.[2021]

In a study involving 20 healthcare workers, wearing either an FFP2 mask alone or in combination with a surgical mask did not significantly affect their oxygen saturation (SpO2) levels or pulse rates over a 60-minute period.

While there were some fluctuations in SpO2 values in the FFP2-surgical mask group, overall, both mask types were found to be safe and did not adversely impact vital signs during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does combined usage of FFP2 and Surgical mask against SARS-CoV-2 affect SpO2 values and pulse rates of dental health-care workers? Bal, C., Aksoy, M., Ozturk, Z., et al.[2022]

Two filtering facepiece respirators (FFR), one prototype and one commercial model, successfully met all eight proposed comfort and tolerance criteria identified by healthcare workers.

Three additional FFR, including two prototypes and one commercial model, passed seven out of eight criteria, indicating that while many designs show promise, further testing is needed to evaluate their overall effectiveness and user compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project BREATHE - Prototype Respirator Evaluation Utilizing Newly Proposed Respirator Test Criteria. Kim, JH., Roberge, RJ., Shaffer, RE., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10602271/

A systematic review of passing fit testing of the masks and ...

The first passing rate was 47% (34 out of 72), and the overall fit pass rate was approximately 79% (63 out of 80). Different mask types and ...

2.

thelancet.com

thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00192-0/fulltext

Relative efficacy of masks and respirators as source control ...

A duckbill N95 reduced exhaled viral load by 98% (95% CI: 97%–99%), and significantly outperformed a KN95 (p < 0.001) as well as cloth and ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1438463925000434

Assessment of the fit and wearability of commercially ...

The purpose of this study was to determine how well KN95 respirators, marketed for children, fit the faces of children aged 6–13 years old in two urban sites.

4.

cdc.gov

cdc.gov/mmwr/volumes/71/wr/mm7106e1.htm

Effectiveness of Face Mask or Respirator Use in Indoor .. ...

Consistent use of a face mask or respirator in indoor public settings was associated with lower odds of a positive SARS-CoV-2 test result.

5.

cureus.com

cureus.com/articles/319824-effectiveness-of-n95-mask-fit-testing-for-the-prevention-of-severe-acute-respiratory-syndrome-coronavirus-2-a-retrospective-case-control-study

Effectiveness of N95 Mask Fit Testing for the Prevention of ...

Higher infection rates were observed among those who failed the N95 mask fit test, thus emphasizing the importance of proper mask use. N95 mask ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11562878/

A review of mask fit testing data associated with protocols ...

Quantitative mask fit testing (QNFT) is the gold standard to confirm the correct fit of a N95/P2 mask to ensure health care workers protection ...

7.

osha.gov

osha.gov/laws-regs/regulations/standardnumber/1910/1910.134AppA

1910.134 App A - Fit Testing Procedures (Mandatory).

The fit test shall be performed while the test subject is wearing any applicable safety equipment that may be worn during actual respirator use which could ...

8.

publichealth.wvu.edu

publichealth.wvu.edu/news/story/?headline=a-mask-q-addressing-common-questions-aboutkn95-n95-mask-and-more

A Mask Q&A: Addressing common questions about the KN95 ...

KN95 and N95 masks are both rated to filter out at least 95% of particles down to 3 microns. The N95 is more effective due to being able to achieve a better ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352013223001047

Effectiveness of fit testing versus fit checking for healthcare ...

Overall, 69% (40/58) of respirators failed quantitative fit testing after initial respirator application and is a clinically relevant finding (first-up failure ...

10.

cdc.gov

cdc.gov/niosh/ppe/respirators/fit-testing.html

Fit Testing | Personal Protective Equipment

OSHA requires an annual fit test to confirm the fit of any respirator that forms a tight seal to your face before you use it in the workplace.