HealthyFACEFITNCT05388201
Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT
An observational study of Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- N95, KN95 and KF94
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female subjects
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Environmental Protection Agency Human Studies Facility
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- N95, KN95, KF94, Surgical
- Keywords
- Healthy Subjects, Mask, Mask Fit, Fitted Filtration Efficiency, Facial Features, Craniofacial Morphology, 3D Facial Imaging, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95Other
3M N95 Respirator
KN95Other
KN95 Mask (with and without clip)
KF94Other
KF94 Mask (with and without clip)
SurgicalOther
Surgical Mask (with and without clip)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: N95; Other: KN95; Other: KF94; Other: Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 5 minutes before mask donning
Secondary outcomes (1)
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.
Measured: Approximately 5 minutes before mask donning and during mask donning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jun 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Responsible party
- Sponsor
- Investigators
- James Samet, PhD, Principal investigator, Environmental Protection Agency (EPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388201
- Sponsor's protocol ID
- 20-2612
- Acronym
- FACEFIT
- Status last verified
- Feb 2024
- First submitted
- 18 May 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39228845
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT
- ClinicalTrials.gov ID
- NCT05388201
- Acronym / sponsor ID
- FACEFIT / 20-2612
- Conditions
- Healthy
- Keywords
- Healthy Subjects, Mask, Mask Fit, Fitted Filtration Efficiency, Facial Features, Craniofacial Morphology, 3D Facial Imaging, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FACEFIT | – | Other: N95, Other: KN95, Other: KF94, Other: SurgicalParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female subjects
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- Individuals with following conditions:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N953M N95 Respirator | Other | FACEFIT |
| KN95KN95 Mask (with and without clip) | Other | FACEFIT |
| KF94KF94 Mask (with and without clip) | Other | FACEFIT |
| SurgicalSurgical Mask (with and without clip) | Other | FACEFIT |
Primary outcome
Fitted Filtration Efficiency (FFE)
Time frame: Approximately 5 minutes after each mask condition
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.
Craniofacial Morphology
Time frame: Approximately 5 minutes before mask donning
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.
1 secondary outcome
3D Facial Imaging
Time frame: Approximately 5 minutes before mask donning and during mask donning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 39228845Griffin 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Samet, PhD principal investigator
Environmental Protection Agency (EPA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitted Filtration Efficiency (FFE) (time frame: Approximately 5 minutes after each mask condition). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.