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Effect of Surgical Masks in Preventing Acute Respiratory Infections
Effect of Surgical Masks in Preventing Acute Respiratory Infections

NCT07739446

Enrolling By InvitationNA

Sponsor: Chiba University

Conditions: Acute Respiratory Infections (ARIs), Influenza, COVID - 19

Interventions: Surgical masks

Countries: Japan

The goal of this clinical trial is to evaluate the efficacy of surgical masks in preventing acute respiratory tract infections. The main question it aims to answer is: \- Does wearing a mask prevent you from getting acute respiratory tract infections, including influenza and COVID-19 Researchers will compare a surgical mask to no intervention to see if wearing a mask works to prevent acute respiratory infection. Participants will: * Wear or not wear a surgical mask every day * Answer a questionnaire every 2 weeks on symptoms, testing status, and behaviors This trial does not assess if wearing a mask prevents transmission of pathogens when you are already sick. Also, the trial does not assess whether universal masking (where everyone wears masks) works.

Eligibility overview

Sex: ALL

Age: 20 Years to 49 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Those who originally do not wear a mask during the influenza season
* Those aged 20 years or older and under 50 years at the time of providing informed consent
* If assigned to the mask group, those who can agree to wear a mask when going outdoors for 3 to 4 months during the influenza season (excluding times such as when eating)
* In the case of the non-mask group, those who can agree, in principle, not to wear a mask for 3 to 4 months during the influenza season
* Those who can agree to undergo testing for both influenza and COVID-19 on the day of onset or the following day if symptoms suggestive of influenza, COVID-19, or a common cold (such as fever or respiratory symptoms) develop, and to visit a medical institution at their own expense for medical fees
* Those who usually go out 3 or more days a week
* Those who have obtained the agreement of cohabiting family members regarding participation
* Those who, after receiving a thorough explanation regarding participation in this study and with full understanding, have provided written informed consent based on their own free will

Exclusion Criteria:

* Those who originally wear a mask during the influenza season and intend to continue doing so in the future
* Those who are engaged in healthcare, food manufacturing, etc., and wear a mask during regular work
* Those who are pregnant
* Those with underlying medical conditions such as chronic liver disease, cancer, or cardiovascular disease
* Those who have previously experienced allergic symptoms when wearing commercially available non-woven masks
* Those who are planning long-term overseas travel exceeding one week during the influenza season, including the New Year holidays‡
* Others who did not provide consent
Locations (1)
  • Chiba, Japan