MasksNCT05216939
Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions
A study testing Flannel mask with ear loops, Flannel mask with ties and Twill mask with ear loops in people with Masks, run by Emory University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Masks
- What is being tested?
- Flannel mask with ear loops, Flannel mask with ties and Twill mask with ear loops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2021to 22 Feb 2022
- Phase
- Interventional
- 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 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Children's Center
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- Masks
- Being tested
- Flannel mask with ear loops, Flannel mask with ties, Twill mask with ear loops, Twill mask with ties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flannel mask with ear loopsOther
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 tiesOther
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.
Twill mask with ear loopsOther
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 tiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Flannel mask with earl loops | Experimental | Participants will wear a flannel mask with earl loops Receives: Other: Flannel mask with ear loops |
| Flannel mask with ties | Experimental | Participants will wear a flannel mask with earl ties Receives: Other: Flannel mask with ties |
| Twill mask with ear loops | Experimental | Participants will wear a twill mask with ear loops Receives: Other: Twill mask with ear loops |
| Twill mask with ties | Experimental | Participants will wear a twill mask with ties Receives: Other: Twill mask with ties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Before and during treadmill use (from start up to 10 minutes)
Secondary outcomes (4)
Change in heart rate
Prior to the treadmill activity, the researcher will clip a pulse rate continuously during the performance of all physical activities. Participants will walk on the treadmill for 10 minutes at either 1.5 or 3 miles per hour while wearing the assigned mask.
Measured: During treadmill: from start up to 10 minutes
Monitoring of oxygen levels
Participants wearing the assigned mask will walk on the treadmill at either 1.5 or 3 miles per hour while their oxygen levels are monitored using a transcutaneous monitor.
Measured: During treadmill: from start up to 10 minutes
Monitoring levels of carbon dioxide
Participants wearing the assigned mask will walk on the treadmill at either 1.5 or 3 miles per hour while their CO2 levels are monitored using a transcutaneous monitor.
Measured: During treadmill: from start up to 10 minutes
Change in perceptions of mask comfort
Survey data on perceived exertion after fit mask test before treadmill use and after treadmill use
Measured: Baseline (Before treadmill use) and immediately after treadmill up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start8 Nov 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MasksStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Colleen S. Kraft, Emory University
- Investigators
- Colleen Kraft, MD, MSc, Principal investigator, Emory UniversityAndrea L Shane, MD MPH MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216939
- Sponsor's protocol ID
- STUDY00001556
- Status last verified
- May 2022
- First submitted
- 23 Nov 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share Individual participant data that underlie the results reported in the article, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions
- ClinicalTrials.gov ID
- NCT05216939
- Acronym / sponsor ID
- STUDY00001556
- Conditions
- Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 1 Feb 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flannel mask with earl loops | Experimental | Other: Flannel mask with ear loopsParticipants will wear a flannel mask with earl loops |
| Flannel mask with ties | Experimental | Other: Flannel mask with tiesParticipants will wear a flannel mask with earl ties |
| Twill mask with ear loops | Experimental | Other: Twill mask with ear loopsParticipants will wear a twill mask with ear loops |
| Twill mask with ties | Experimental | Other: Twill mask with tiesParticipants will wear a twill mask with ties |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Flannel mask with ear loopsParticipants 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. | Other | Flannel mask with earl loops |
| Flannel mask with tiesParticipants 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. | Other | Flannel mask with ties |
| Twill mask with ear loopsParticipants 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. | Other | Twill mask with ear loops |
| Twill mask with tiesParticipants 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. | Other | Twill mask with ties |
Primary outcome
Change in Effect of masks textile types and designs on user discomfort
Time frame: Before treadmill and after treadmill use (15 minutes)
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.
Change in the Effect of masks textile types and designs on their ability to stay in place.
Time frame: Before and during treadmill use (from start up to 10 minutes)
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).
4 secondary outcomes
Change in heart rate
Time frame: During treadmill: from start up to 10 minutes
Monitoring of oxygen levels
Time frame: During treadmill: from start up to 10 minutes
Monitoring levels of carbon dioxide
Time frame: During treadmill: from start up to 10 minutes
Change in perceptions of mask comfort
Time frame: Baseline (Before treadmill use) and immediately after treadmill up to 10 minutes
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 17 May 2022.
- Individual participant dataSharing planned: Yes. The research team will share Individual participant data that underlie the results reported in the article, after deidentification.
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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.
Colleen Kraft, MD, MSc principal investigator
Emory University
Andrea L Shane, MD MPH MSc principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flannel mask with ear loops, Flannel mask with ties and Twill mask with ear loops in people with Masks, run by Emory University at 2 sites 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 15 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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Effect of masks textile types and designs on user discomfort (time frame: Before treadmill and after treadmill use (15 minutes)). 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?
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 17 May 2022.