Status:
COMPLETED
Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Environmental Protection Agency (EPA)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05388201
Start Date
June 1 2022
End Date
August 30 2023
Last Update
February 29 2024
Active Locations (1)
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1
U.S. Environmental Protection Agency Human Studies Facility
Chapel Hill, North Carolina, United States, 27514