Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0)

NCT06425588 | Suspended

• 2 other identifiers: 24-0349FACEFIT 2.0
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the role of craniofacial dimensions and self-evaluation thereof in the protection afforded by masks commonly worn by the public as protection against aerosol contaminants. The effectiveness of instructions for self-evaluation of craniofacial dimensions will be tested against standard digital and manual craniometric methods. Approximately 500 (18+ year old) subjects. There will be two groups to complete this study (Group A and B). After consenting to participate in the study, subjects in Group A will use a short self-assessment questionnaire to measure their craniofacial dimensions, fill out a questionnaire, and have their face measured using standard anthropological techniques and a 3D camera. They will then enter a chamber containing an atmosphere of aerosolized salt particles where the fitted filtering efficiency of 2 types of face masks will be measured briefly. Subjects in Group B will only complete the craniometric assessment, self-assessment, and questionnaire. Participation time is approximately 60 minutes for Group A and 15 minutes for Group B.

Conditions

Healthy

Keywords

Healthy subjects; Mask; Mask fit; Fitted Filtration Efficiency; Self-Evaluation; Craniofacial Morphology; 3D imaging

Outcome Measures

Primary Outcomes (2)

• Fitted Filtration Efficiency

  A mask fit procedure will be performed based on an OSHA (Occupational Safety and Health Administration)- 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.

  During fitting procedure (90 seconds for each condition)

• Cranial Morphology- Self Evaluation

  Cranial morphology will be assessed using a self-evaluation that guides participants on how to measure five dimensions of their head/face including: nose length, nose arc, face width, neck circumference, and ear breadth. Participants will record their measurement for each cranial/facial features using the instructions provided on the self-evaluation form. Investigators will then use the five recorded values to cluster each participant into one of four categories of overall face and head shape/size.

  The self-evaluation will take approximately ten minutes and be filled out once during the study visit (Day 1).

Secondary Outcomes (3)

• Cranial Morphology- Caliper Measurement

  The craniometric assessment will take approximately 5 minutes and be completed before the fit testing procedure.

• Cranial Morphology- 3D Imaging

  The 3D imaging will take approximately 5 minutes and be completed before the fit testing procedure.

• FaceFit 2.0 Face Filtering PIece Usage Survey

  This survey will take about five minutes and be completed before the mask fit testing.

Study Arms (2)

Mask Testing

EXPERIMENTAL

All participants will be fit tested while completing a modified version of the OSHA fit test. The subject will remain seated in the chamber and complete a modified version the Occupational Safety and Health Administration Quantitative Fit Testing Protocol (Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for Filtering Facepiece TableA-2-RESPIRATORS). The subject will then move their head from left to right, taking two breaths at each extreme for 30 seconds. This will be followed by moving the head up and down, taking two beaths at each extreme for 30 seconds. The procedure will be repeated after the addition of a clip to the ear-loops of the mask behind the neck of the subject. In total, the testing time for the 2 masks with and without clip will be approximately 6 minutes.

Other: Surgical/Procedure Mask Fit Testing; Other: KN95 Mask Fit testing

Craniometric and Behavioral Assessment

NO INTERVENTION

First, the subjects height and weight will be measured using standard methods (scale and stadiometer). They will be asked to remove their shoes and empty their pockets before being weighed. Four to eight face, head, and neck features will also be measured using spreading and sliding calipers and a measuring tape. Trained personnel (wearing gloves) will palpate the subjects face and to ensure proper caliper measurements are collected. Cosmetic pencils will be used to identify landmarks on the face and neck in order assist in the measurement of craniofacial features. Following facial measurements, a study team member will take a 3D picture of the subject's face using a camera. The image takes approximately 10 seconds to generate. We will first position the subject in from of the camera and ask them to tighten any loose hair so we can have a clear view of their ears. It is recommended that subjects wear a non-collared shirt, preferably a t-shirt. If they wea

Interventions

Surgical/Procedure Mask Fit Testing OTHER

All participants will wear a surgical/procedure mask and be fit tested using a modified version of the OSHA quantitative fit testing procedure.

Mask Testing

KN95 Mask Fit testing OTHER

All participants will wear a KN95 mask and be fit tested using a modified version of the OSHA quantitative fit testing procedure.

Mask Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Group A:
• Not feeling well.
• Unable to walk unassisted, stand or sit still for 15 minutes at a time.
• Suffered a heart attack, cardiac arrest or stroke in the past 6 months.
• Have been hospitalized overnight or sought urgent medical care in the last 30 days.
• Pregnant, attempting to become pregnant or breastfeeding.
• BMI (kg/m2) of ≤16.0 or ≥ 50.0
• Have a facial hair style that will interfere with the facemask seal.
• Group B:
• Not feeling well.
• Unable to sit still for 5 minutes

Sponsors & Collaborators

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

Study Sites (1)

U.S. Environmental Protection Agency Office of Research and Development

Durham, North Carolina, 27709, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• James Samet, PhD

  U.S. Environmental Protection Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 22, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-02

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)