Mask Fit Testing for Healthy Subjects

Not currently recruiting at 1 trial location
RK
PR
Overseen ByPatrice Ratliffe
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

Who Is on the Research Team?

JS

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
See 1 more

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.
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Mask TestingExperimental Treatment2 Interventions
Group II: Craniometric and Behavioral AssessmentActive Control1 Intervention

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

🇨🇳
Approved in China as KN95 Respirator for:
🇪🇺
Approved in European Union as FFP2 Mask for:
🇺🇸
Approved in United States as KN95 Respirator for:

Find a Clinic Near You

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

Citations

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 ...
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 ...
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.
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.
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 ...
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 ...
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 ...
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 ...
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 ...
Fit Testing | Personal Protective EquipmentOSHA 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.
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