Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions

NCT05216939 | Completed

• 1 other identifier: STUDY00001556
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Masks

Outcome Measures

Primary Outcomes (2)

• Change in Effect of masks textile types and designs on user discomfort

  In order to better understand the effectiveness of different cloth masks for source control, the research team will assess the usability of the optimal masks through simulations by measuring comfort by using the optimal combinations of head suspension and mask designs. Participants will rate the discomfort of the mask they come in wearing and then rate the discomfort of the test mask they wear during the study after walking on a treadmill. Participants will answer the Discomfort of Cloth Masks-12 (DCM-12) scale which is comprised of 12 questions. For each item, there are four choices that correspond to four levels of discomfort: 1 (not at all), 2 (a little bit), 3 (somewhat), 4 (very much so). Items 1, 2, 4, 8, 10, and 12 will be used to obtain a subscale-score for breathability-related discomfort. Items 3, 5, 6, 7, 9, and 11 will be used to obtain a subscale-score for tightness-related discomfort. A higher score reflects a higher discomfort.

  Before treadmill and after treadmill use (15 minutes)

• Change in the Effect of masks textile types and designs on their ability to stay in place.

  In order to better understand the effectiveness of different cloth masks for source control, the research team will assess the usability of the optimal masks through simulations by measuring the ability of the mask to stay in place. The research team will use a tally during the treadmill activity across the following: Touching face (no mask), touching mask (but no removing), Removed mask (remind to put back on).

  Before and during treadmill use (from start up to 10 minutes)

Secondary Outcomes (4)

• Change in heart rate

  During treadmill: from start up to 10 minutes

• Monitoring of oxygen levels

  During treadmill: from start up to 10 minutes

• Monitoring levels of carbon dioxide

  During treadmill: from start up to 10 minutes

• Change in perceptions of mask comfort

  Baseline (Before treadmill use) and immediately after treadmill up to 10 minutes

Study Arms (4)

Flannel mask with earl loops

EXPERIMENTAL

Participants will wear a flannel mask with earl loops

Other: Flannel mask with ear loops

Flannel mask with ties

EXPERIMENTAL

Participants will wear a flannel mask with earl ties

Other: Flannel mask with ties

Twill mask with ear loops

EXPERIMENTAL

Participants will wear a twill mask with ear loops

Other: Twill mask with ear loops

Twill mask with ties

EXPERIMENTAL

Participants will wear a twill mask with ties

Other: Twill mask with ties

Interventions

Flannel mask with ear loops OTHER

Participants will have a mask fit test and will wear a flannel mask with ear loops. While wearing the flannel mask, participants will perform a sequence of activities. 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. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort and fit of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

Flannel mask with earl loops

Flannel mask with ties OTHER

Participants will have a mask fit test and will wear a flannel mask with ties. While wearing the flannel mask, participants will perform a sequence of activities. 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. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

Flannel mask with ties

Twill mask with ear loops OTHER

Participants will have a mask fit test and will wear a twill mask with ear loops. While wearing the twill mask with ear loops, participants will perform a sequence of activities. 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. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

Twill mask with ear loops

Twill mask with ties OTHER

Participants will have a mask fit test and will wear a twill mask with ties. While wearing the twill mask with ties, participants will perform a sequence of activities. 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. Participants will be assigned to a specific speed on a treadmill with no incline, either 1.5 mph, the 'light' activity level, or 3 mph, the 'moderate' activity level. They will walk on the treadmill for 10 minutes. Prior to the treadmill activity, participants will rate the comfort of the mask. Near the end of the activity, participants will rate their perceived exertion and again rate the comfort of the mask. Participants will complete a post-experiment questionnaire following all activities.

Twill mask with ties

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Colleen Kraft, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

• Andrea L Shane, MD MPH MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: February 1, 2022
• Study Start: November 8, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The research team will share data Immediately following the publication and ending 36 months following publication.
• Access Criteria: All proposals should be directed to jmmumma@emory.edu. To gain access, data requestors will need to sign a data access agreement

Locations

US (2)