Clinical trial NCT05216939: Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions
Official title: Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Masks
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Cloth masks have been evaluated as a potential substitute for personal protective equipment (PPE) and found lacking. Prior to the COVID-19 outbreak, the use of cloth masks was limited and the focus of the limited research available was on the filtration of various fabrics in comparison to either surgical masks or N95 respirators. The Centers for Disease Control and Prevention (CDC) guidance for the coronavirus (COVID-19) outbreak makes it clear that cloth masks are not to be considered as PPE for healthcare workers and should be used in the healthcare setting only as a last resort when no other masks or respirators are available. While cloth masks are not recommended to be used as PPE, the use of cloth masks as primary source control has not yet been examined.

Detailed description: This study will recruit children ages 6-11 and adults ages 18-65 living in the Atlanta/Metro-Atlanta area.

Participants will be randomly assigned to wear one of four different masks. These masks are created by combining one of two different kinds of fabric (flannel or twill) and one of two attachment devices (elastic ear loops or fabric ties). Additionally, adult participants will be randomly assigned to wear the mask while walking on a treadmill at either 1.5 mph or 3.0 mph. While wearing each mask, participants will perform the following sequence of activities: In a normal standing position, participants will 1) breathe normally (without talking), 2) breathe slowly and deeply, taking caution so as not to hyperventilate, 3) slowly turn his/her head from side to side between the extreme positions on each side, 4) slowly move his/her head up and down, inhaling in the up position (i.e., when looking toward the ceiling), 5) count up from 0-20 loudly and slowly, 6) grimace by smiling or frowning, 7) bend at the waist as if he/she were to touch his/her toes, and 8) breathe normally (without talking). Each activity will be performed for 1 minute, except for the grimace exercise, which will be performed for 15 seconds.

During the first two activities, the researcher will hold a mirror at each edge of the mask (nose, cheeks, and chin) to monitor whether there is fogging on the mirror. For the rest of the exercises, the researchers will note whether the mask lost its fit (e.g., slipping off the nose or face). Between activities, participants will be told to re-adjust the mask.

In the second phase of research activities, participants will walk on a treadmill while wearing their randomly assigned mask. Adult participants will be assigned to a specific speed on the treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. Child participants will only walk at 1.5 mph. Participants will walk on the treadmill for 10 minutes. Prior to the treadmill activity, the researcher will clip a probe to the participant's ear lobe that will measure transcutaneous carbon dioxide (CO2) (i.e., non-invasively) and pulse rate continuously during the performance of all physical activities. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will their perceived exertion and again rate the comfort of the mask. During the activity, participants will be free to adjust their masks as often as needed to maintain comfort and fit. The researcher will tally the frequency at which each participant adjusts their mask and the number of times that the mask lost its fit (e.g., slipping off the nose or face) and was not adjusted. Participants will complete a post-experiment questionnaire following all activities.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6-11 years old
* Adults aged 18-65
* Adults who have never smoked or have smoked less than 100 cigarettes in their lifetime

Exclusion Criteria:

* Adults unable to consent
* Pregnant women
* Prisoners
* Cognitively impaired or Individuals with Impaired Decision-Making Capacity
* Individuals who are not able to clearly understand English
* Our research team does not have the resources required to translate our study materials or provide a translator for the study visit
* Any known cardiorespiratory condition (including but not limited to asthma, bronchitis, cystic fibrosis, congenital heart disease, and emphysema)
* Any known medical conditions that can be exacerbated by physical exercise (including but not limited to exercise-induced asthma, lower respiratory infections in the past 2 weeks, diabetes, hypertension, or epilepsy/seizure disorders)
* Any physical disability from a medical, orthopedic, or neuromuscular disorder that would interfere with the performance of physical activities
* Adult participants who are current or former smokers (i.e., an adult who has smoked 100 cigarettes in their lifetime and who currently smoke cigarettes, or an adult who has smoked 100 or more cigarettes in their lifetime)
* Inability to move the head from side to side or bend at the waist
* Inability to walk on a treadmill unassisted for the study duration
* Inability to tolerate wearing a mask while completing physical activities
* Anyone with symptoms of COVID-19 in the two weeks before their study visit
* Presence of an acute upper respiratory tract infection or symptomatic rhinitis (i.e., blocked nasal passages, runny nose, or significant sneezing) on the day of the study

Primary outcomes:
measure: Change in Effect of masks textile types and designs on user discomfort
timeFrame: Before treadmill and after treadmill use (15 minutes)
measure: Change in the Effect of masks textile types and designs on their ability to stay in place.
timeFrame: Before and during treadmill use (from start up to 10 minutes)
Secondary outcomes:
measure: Change in heart rate
timeFrame: During treadmill: from start up to 10 minutes
measure: Monitoring of oxygen levels
timeFrame: During treadmill: from start up to 10 minutes
measure: Monitoring levels of carbon dioxide
timeFrame: During treadmill: from start up to 10 minutes
measure: Change in perceptions of mask comfort
timeFrame: Baseline (Before treadmill use) and immediately after treadmill up to 10 minutes
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Colleen Kraft, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Andrea L Shane, MD MPH MSc
role: PRINCIPAL_INVESTIGATOR
References: