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NCT05388201 · ClinicalTrials.gov registry record
Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT
A clinical trial of Healthy, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT05388201: Completed study of Healthy, sponsored by University of North Carolina, Chapel Hill.
NCT05388201 is a study of Healthy that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 100 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388201, a study of Healthy, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER N95
- OTHER KN95
- OTHER KF94
- OTHER Surgical
Study Locations (1)
North Carolina
- U.S. Environmental Protection Agency Human Studies Facility - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2023-08-30 |
What the finished NCT05388201 record still lists
NCT05388201 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which N95 is the first listed.
NCT05388201 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05388201 about?
NCT05388201 is a clinical study titled "Variation In Facial Morphology As A Determinant Of Face Covering Performance: FACEFIT". 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 p...
What is the current status of trial NCT05388201?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2022-06-01. Estimated completion is 2023-08-30.
What conditions does trial NCT05388201 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05388201?
The interventions under investigation include: N95 (OTHER), KN95 (OTHER), KF94 (OTHER), Surgical (OTHER).
Who is sponsoring clinical trial NCT05388201?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05388201 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05388201's enrollment target sits among peer trials
100 219th of 1090 higher than 851 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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