Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT (FACEFIT)

This study examines the role of variations in the dimensions of facial features on the fitted filtering efficiency of face coverings available to the public during the COVID-19 pandemic. Approximately 100 young (18-55 years old) healthy participants will be recruited. Exclusionary criteria include pregnancy and breastfeeding. After informed consent, participants will enter a chamber where they will undergo 3D facial scanning using a dedicated camera system and be trained to don an N95 respirator properly. The fitted filtering efficiency (FFE) of 4 types of face coverings: a N95 respirator, a KN95 respirator (with and without a clip), a surgical mask (with and without a clip), and a KF94 respirator (with and without a clip) will be tested on each participant using the OSHA quantitative fit testing protocol for filtering face pieces.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: N95; Other: KN95; Other: KF94; Other: Surgical

Detailed Description

Consenting: The investigators will review the inclusion and exclusion criteria and any medical conditions that the participant may have or medications that they are currently taking. The investigators will go over the study protocol in detail so that the participant will know what to expect during the study procedure.

Lung Function Test: The participant will perform a breathing test (peak flow meter) before and after the facemask testing. This test measures the volume of air that the participant can blow out (exhale) quickly after taking a very deep breath. This is a method for measuring lung function and it must meet certain criteria prior to testing.

3D Facial Measurement and Imaging: The participants 3D facial features will be measured by facial calipers. Trained personnel (wearing gloves) will need to touch areas of the participants face and scalp to ensure proper caliper measurements are collected. A 3D picture of the participants face will be taken using a special 3D camera.

Video Instruction on Wearing an N-95 Respirator: The participant will watch a short video showing proper ways to wear an N-95 respirator.

Assessment of the Performance of Face Coverings: The participant will enter a study chamber where tiny sodium chloride (table salt) particles are emitted by a particle generator. The participant will be fit tested wearing different types of face coverings that include an N95-rated respirator, a KN95 mask (with and without clip), a surgical mask (with and without clip), and a KF94 respirator (with and without clip). During the test, the participant will be asked to perform a few tasks such as bending over, talking, etc. 3D images of the participants head, while wearing the masks, will be taken following each test.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • U.S. Environmental Protection Agency Human Studies Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female subjects

Description

Inclusion Criteria:

• Age 18-55 years old healthy male and female (BMI values between 19 and 33, inclusive).
• Participants must be ambulatory and tolerate enclosed spaces.
• Participants must be up to date with their COVID-19 vaccination status based on the current recommendations established by the CDC.

Exclusion Criteria:

• Individuals with following conditions:

  • A history of acute or chronic cardiovascular disease, chronic respiratory disease, cancer, rheumatologic disease, neuromuscular disease, or immunodeficiency state.
  • Blood pressure readings equal to and greater than 140 systolic and equal to and greater than 90 diastolic.
  • Diabetes.
  • Asthma or a history of asthma.
• Individuals who have unspecified illnesses, which in the judgment of the medical staff might increase the risk associated with saline aerosol inhalation will be a basis for exclusion.
• Medications not specifically mentioned here may be reviewed by the medical staff prior to an individual's inclusion in the study. Use of other medications will be evaluated on a case-by-case basis. There is the potential that an individual's current medication use will preclude them from participating in the study at the current time, but they may be reassessed and potentially rescheduled for participation later based on the judgement of the medical staff.
• Individuals who are pregnant, attempting to become pregnant or breastfeeding.
• Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study or have a greater than/equal to a 5-pack year smoking history.
• Individuals living with a smoker who smokes inside the house.
• Individuals who are regularly exposed to high levels of vapors, dust, gases, or fumes.
• Individuals who do not read, speak, or understand English well enough to give informed consent.
• Individuals who are unwilling to shave facial hair.
• Individuals who have orthopedic or balance issues that prevent them from performing the steps in the mask fit testing protocol, such as bending over, turning head left and right or up and down.
• Individuals who recently had abdominal and/or eye surgery, or with any types of hernia, as well as any other contraindications for raised intra-abdominal pressure in the last 6 months.

Temporary exclusion criteria:

• Individuals who have experienced any symptoms associated with acute respiratory illness within 4 weeks of enrollment.
• Individuals who have active allergies.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

FACEFIT; Participants will enter a chamber where they will undergo 3D facial scanning using a dedicated camera system and be trained to don a N95 respirator properly. The fitted filtering efficiency (FFE) of 4 types of face coverings: a N95 respirator, a KN95 respirator (with and without a clip), a surgical mask (with and without a clip), and a KF94 respirator (with and without a clip) will be tested using the OSHA quantitative fit testing protocol for filtering face pieces. Participants will measure their peak expiratory flow pre and post mask fit testing using a disposable peak flow meter.

Other: N95; 3M N95 Respirator; Other: KN95; KN95 Mask (with and without clip); Other: KF94; KF94 Mask (with and without clip); Other: Surgical; Surgical Mask (with and without clip)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitted Filtration Efficiency (FFE)	A mask fit procedure will be performed based on a NIOSH (National Institute of Occupational Safety and Health) - approved protocol during the baseline visit. The efficiency of masks will be determined by a percentage of particle number measured behind the facemask over the particle number in the ambient air. Mask fit efficiency values from different levels of mask fit instructions will be compared.	Approximately 5 minutes after each mask condition
Craniofacial Morphology	Calipers will be used to measure 3D facial features of each subject. Trained personnel (wearing gloves) will need to touch areas of the subject's face and scalp to ensure proper caliper measurements are collected.	Approximately 5 minutes before mask donning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D Facial Imaging	Subjects will self-administer a 3D scan of their face by aligning their head inside of an oval shown on the camera screen, triggering the camera shutter. The image takes about 3 seconds to generate and subjects will be asked to remain still during this time. The acquired facial images will be analyzed using digital image analysis software.	Approximately 5 minutes before mask donning and during mask donning

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Environmental Protection Agency (EPA)
• Investigators: Principal Investigator: James Samet, PhD, Environmental Protection Agency (EPA)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Healthy Subjects; Mask; Facial Features; Mask Fit; Fitted Filtration Efficiency; Craniofacial Morphology; 3D Facial Imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: 20-2612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data will be shared through the U.S. EPA's ScienceHub database. ScienceHub is used to upload and store datasets associated with journal articles. Non-sensitive datasets are then made publicly accessible via the Environmental Dataset Gateway in fulfillment of the EPA's requirement to adhere to the Office of Management and Budget's Open Data Policy.
• IPD Sharing Time Frame: The data will be available to the public after the conclusion of the study and the publication of the manuscripts.
• IPD Sharing Access Criteria: Data will be available at the U.S. EPA Science Hub.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No