Mask Fit Testing for Healthy Subjects
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Consent and Initial Assessment
Participants provide informed consent and complete initial assessments including a behavioral questionnaire and craniofacial measurements
Mask Fit Testing
Participants undergo mask fit testing using aerosolized sodium chloride particles to measure fitted filtration efficiency
Follow-up
Participants are monitored for any immediate adverse effects post mask fit testing
What Are the Treatments Tested in This Trial?
Interventions
- KN95 Mask Fit testing
- Surgical/Procedure Mask Fit Testing
KN95 Mask Fit testing is already approved in China, European Union, United States for the following indications:
- Protection against airborne pathogens
- Prevention of respiratory infections
- Protection against airborne pathogens
- Prevention of respiratory infections
- Emergency Use Authorization for protection against COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Environmental Protection Agency (EPA)
Collaborator