Examining how face mask fit is influenced by facial dimensions
Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0)
This study tests how different face shapes affect the fit and protection of commonly used face masks to help people choose the right one for better safety against airborne particles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06425588 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between craniofacial dimensions and the effectiveness of commonly used face masks in protecting against aerosol contaminants. Participants will complete a self-assessment questionnaire to measure their craniofacial dimensions, which will then be compared to measurements taken using standard techniques and a 3D camera. The fitted filtration efficiency of two types of face masks will be tested in a controlled environment with aerosolized salt particles. The goal is to provide individuals with a better understanding of how to choose masks that fit them properly, enhancing their protection against airborne threats.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-70 who can tolerate enclosed spaces and are able to complete a self-assessment.
Not a fit: Patients who are pregnant, have facial hair, or have recent respiratory illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower individuals to select more effective masks, improving their protection against airborne contaminants.
How similar studies have performed: While studies on mask efficacy exist, this approach of self-assessing craniofacial dimensions for mask fit is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-70 years old healthy of any gender and ethnicity. 2. Subjects must be ambulatory and tolerate enclosed spaces. 3. Subjects must report being in good health 4. Individuals with a BMI (kg/m2) that is greater than 16.0 and less than 50.0 Exclusion Criteria: 1. Persons who are pregnant, attempting to become pregnant or breastfeeding 2. Persons who are unable to read English or Spanish well enough to follow written instructions or a questionnaire. 3. Persons who have facial hair. 4. Individuals who have had an acute respiratory illness within 4 weeks. 5. Individuals who have active allergies. 6. Those who are not feeling well. 7. Anyone who is unable to walk unassisted, stand or sit still for 15 minutes at a time. 8. Anyone who suffered a heart attack, cardiac arrest or stroke in the past 6 months. 9. Anyone who has been hospitalized overnight or sought urgent medical care in the last 30 days. 10. Anyone who has an unspecified illness, which in the judgment of the medical staff, might increase the risk associated with this study will be a basis for exclusion. 11. Those who are pregnant, attempting to become pregnant or breastfeeding.
Where this trial is running
Chapel Hill, North Carolina
- U.S. Environmental Protection Agency Human Studies Facility — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: James Samet, PhD — U.S. Environmental Protection Agency
- Study coordinator: Robin Kaminski
- Email: Kaminski.Robin@epa.gov
- Phone: (919) 966-0604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.