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

NCT05388201 | Completed

• 1 other identifier: 20-2612
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy Subjects; Mask; Mask Fit; Fitted Filtration Efficiency; Facial Features; Craniofacial Morphology; 3D Facial Imaging; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 3D Facial Imaging

  Approximately 5 minutes before mask donning and during mask donning

Study Arms (1)

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; Other: KN95; Other: KF94; Other: Surgical

Interventions

N95 OTHER

3M N95 Respirator

FACEFIT

KN95 OTHER

KN95 Mask (with and without clip)

FACEFIT

KF94 OTHER

KF94 Mask (with and without clip)

FACEFIT

Surgical OTHER

Surgical Mask (with and without clip)

FACEFIT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female subjects

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Environmental Protection Agency (EPA): collaborator

Study Sites (1)

U.S. Environmental Protection Agency Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Griffin JS, McInroe EM, Pennington ER, Steinhardt W, Chen H, Prince SE, Samet JM. Craniometric determinants of the fitted filtration efficiency of disposable masks. Front Public Health. 2024 Aug 20;12:1444411. doi: 10.3389/fpubh.2024.1444411. eCollection 2024.

  PMID: 39228845 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

N95 Respirators; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• James Samet, PhD

  Environmental Protection Agency (EPA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: June 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available to the public after the conclusion of the study and the publication of the manuscripts.
• Access Criteria: Data will be available at the U.S. EPA Science Hub.

Locations

US (1)