Assessment of Cloth Face Coverings as Source Control Under Laboratory and Simulated Field Conditions
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30322
- Emory University
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Atlanta、Georgia、アメリカ、30322
- Emory Children's Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Flannel mask with earl loops
Participants will wear a flannel mask with earl loops
|
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.
|
|
実験的：Flannel mask with ties
Participants will wear a flannel mask with earl ties
|
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.
|
|
実験的：Twill mask with ear loops
Participants will wear a twill mask with ear loops
|
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.
|
|
実験的：Twill mask with ties
Participants will wear a twill mask with ties
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Effect of masks textile types and designs on user discomfort
時間枠：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.
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Before treadmill and after treadmill use (15 minutes)
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Change in the Effect of masks textile types and designs on their ability to stay in place.
時間枠：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).
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Before and during treadmill use (from start up to 10 minutes)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in heart rate
時間枠：During treadmill: from start up to 10 minutes
|
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.
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During treadmill: from start up to 10 minutes
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Monitoring of oxygen levels
時間枠：During treadmill: from start up to 10 minutes
|
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.
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During treadmill: from start up to 10 minutes
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Monitoring levels of carbon dioxide
時間枠：During treadmill: from start up to 10 minutes
|
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.
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During treadmill: from start up to 10 minutes
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Change in perceptions of mask comfort
時間枠：Baseline (Before treadmill use) and immediately after treadmill up to 10 minutes
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Survey data on perceived exertion after fit mask test before treadmill use and after treadmill use
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Baseline (Before treadmill use) and immediately after treadmill up to 10 minutes
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Colleen Kraft, MD, MSc、Emory University
- 主任研究者：Andrea L Shane, MD MPH MSc、Emory University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00001556
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- 分析コード
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。