NCT04474028

Brief Summary

The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

July 12, 2020

Last Update Submit

November 4, 2020

Conditions

Respiratory Infectious Diseases

Outcome Measures

Primary Outcomes (1)

  • can or can't fell bitterness

    1. Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. 2. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.

    Immediately after spray test

Study Arms (2)

Hood group

The subject wears a mask and a hood, opens his/her mouth to breathe, and sticks out his/her tongue properly. Using the fitness test reagent to spray into the hood.

Direct spray group

The subject wears a mask and his/her tongue sticks out properly. The suitability test reagent is used to spray directly to the subject from the top, bottom, left side and right side twice respectively.

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Those who are 7 years old or above, have the ability of autonomous behavior and language expression, are willing to take the test.

You may qualify if:

  • Healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, Persons under the age of 18 need to obtain the consent of their legal guardians；
  • The subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects；
  • People who volunteered to take part in the study；
  • There was no respiratory infection in nearly one month.

You may not qualify if:

  • People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
  • People with any history of drug allergy；
  • People who have participated in the experiment are not allowed to participate in this study for the second time;
  • Pregnant women；
  • The healer after COVID-19 's infection；
  • After questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test；
  • Those who are participating in clinical trials of other drugs / devices；
  • Subjects with poor compliance or unwilling to cooperate with the operation as required；
  • The researchers believe that any other situation that may affect the evaluation of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fuwai hospital, Beijing

Beijing, Beijing Municipality, 100037, China

Location

Taizhou Health Bureau

Taizhou, Jiangsu, 225300, China

Location

Jiexiu Health Bureau

Jinzhong, Shanxi, 032005, China

Location

Yuanqu Health Bureau

Yuncheng, Shanxi, 043700, China

Location

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, 650000, China

Location

Luliang Health Bureau

Qujing, Yunnan, 655601, China

Location

Shizong Health Bureau

Qujing, Yunnan, 655700, China

Location

Luoping Health Bureau

Qujing, Yunnan, 655816, China

Location

Study Officials

  • Xiang-Bin Pan

    Fuwai Yunnan Cardiovascular Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 16, 2020

Study Start

June 19, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)