SUSPENDED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-30
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06425588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Not feeling well.
  2. * Unable to walk unassisted, stand or sit still for 15 minutes at a time.
  3. * Suffered a heart attack, cardiac arrest or stroke in the past 6 months.
  4. * Have been hospitalized overnight or sought urgent medical care in the last 30 days.
  5. * Have 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.
  6. * Pregnant, attempting to become pregnant or breastfeeding.
  7. * BMI (kg/m2) of ≤16.0 or ≥ 50.0
  8. * Have a facial hair style that will interfere with the facemask seal.
  9. * Not feeling well.
  10. * Unable to sit still for 5 minutes

Contacts and Locations

Principal Investigator

James Samet, PhD
PRINCIPAL_INVESTIGATOR
U.S. Environmental Protection Agency

Study Locations (Sites)

U.S. Environmental Protection Agency Office of Research and Development
Durham, North Carolina, 27709
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • James Samet, PhD, PRINCIPAL_INVESTIGATOR, U.S. Environmental Protection Agency

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-30
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2024-05-30
Study Completion Date2026-05-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Healthy