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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06374316
Other study ID # 2302888
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date May 1, 2024

Study information

Verified date February 2024
Source Norwegian Institute of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate the acceptability and feasibility of deploying air purifiers equipped with HEPA (high-efficiency particulate air) filters in classrooms, to study air purifiers as an infection control measure. It will also evaluate the direct effect of air purifiers on air quality, comparing ceiling-mounted purifiers, portable purifiers and no purifier.


Description:

Improved ventilation and air purification have been proposed as promising measures to protect the health of students and children while avoiding future school closures during pandemics. However, there is limited knowledge regarding the effectiveness and potential drawbacks of using air purifiers in educational settings. This pilot study was initiated to explore whether a large study of air purifiers in Norwegian primary school classrooms is feasible and acceptable among teachers and students, and to uncover whether air purifiers can reduce particle density in classrooms and thus potentially decrease the spread of infections. The results will lay the groundwork for larger-scale trials that could form the basis of knowledge for decision-makers on whether the use of air purifiers should be part of the strategy to limit infections in classrooms while avoiding school closures during future pandemics. The pilot study consists of two parts. The first part will last six weeks, and focus on the feasibility and acceptability among teachers and students. It will describe and compare two arms - ceiling-mounted (arm 1) and portable (arm 2) air purifiers. The second part lasts nine weeks, and will evaluate the direct effect of air purifiers on air quality. It will compare ceiling-mounted, and portable devices and no purifier(arm 3). The study will involve multiple schools, with a total of six schools contributing eight classrooms. Arm 1 will have two schools and arm 2 will have three schools, each school contributing with one classroom. Arm 3 will have one school, contributing with three classrooms. The classrooms will preferably belong to 7th grade students, but 6th and 5th grade student classrooms will also be accepted, based on the schools preferences. Data collection includes interviews and questionnaires from teachers and students, observations, as well as absenteeism data and air quality measurements.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria for Schools in arm 1 and 2: - Having a classroom in the 5th to 7th grade that either has sufficient floor space to accommodate at least two portable air purifiers or has the infrastructure for the installation of a ceiling-mounted air purifier. - Having at least 15 students in the relevant classroom. Inclusion Criteria for Schools in arm 3: - Having three classrooms at the same floor with sufficient floor space to accommodate at least two portable air purifiers AND with the infrastructure for the installation of a ceiling-mounted air purifier. - The relevant three classrooms should be slightly comparable with regards to use and air quality. The air quality, as perceived by users, should generally be rated as moderate to poor. which should be medium to poor. Inclusion Criteria for Students in arm 1 and 2: - Having a classroom with installed air purifier through the study as their primary classroom. - Informed consent from both legal guardians. Inclusion Criteria for Teachers in arm 1, 2, and 3: - Teaching in the classroom with installed air purifiers at least a few hours per week. - Providing informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ceiling-Mounted Air Purifiers
The devices will be turned on every working day except Tuesdays. Air purifiers will be set at levels perceived as acceptable by both teachers and students during operational hours.
Portable Air Purifiers
The devices will be turned on every working day except Tuesdays. Air purifiers will be set at levels perceived as acceptable by both teachers and students during operational hours.
Portable or Ceiling Mounted Air Purifiers
The Ceiling-Mounted and Portable devices will alternate weekly between being activated and deactivated in the three classrooms. Each classroom will also have three weeks with no purifier activated.This alternating pattern aims to assess the impact of the various air purifiers on air quality. Air purifiers will be set at levels perceived as acceptable by both teachers and students during operational hours.

Locations

Country Name City State
Norway Norwegian Institute of Public Health Oslo

Sponsors (2)

Lead Sponsor Collaborator
Norwegian Institute of Public Health SINTEF Health Research

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms. Air quality will be measured using specialized monitors, capturing key indicators such as particulate matter levels. The data collected will enable a comprehensive evaluation of the effectiveness of air purifiers versus no air purifier in improving the overall air quality in educational settings. 9 weeks
Primary Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms. Air quality will be measured using specialized monitors, capturing key indicators such as particulate matter levels. The data collected will enable a comprehensive evaluation of the effectiveness between ceiling mounted and portable air purifiers in improving the overall air quality in educational settings. 9 weeks
Primary Acceptability of having Air Purifiers in Classrooms Acceptability will be assessed through the in-depth qualitative interviews with teachers and students, exploring perceptions and challenges associated with the use of air purifiers. 6 weeks
Primary Untoward events when installing air purifiers in classrooms Experiences will be collected from the personnel involved in installing the air purifiers 2 weeks
Primary Untoward events when running air purifiers in classrooms Experiences will be collected from class teachers and students through in-depth qualitative interviews at the beginning (only teachers) and the end (teachers and students) of the study period. Observations and experiences from the study team during the study period will be collected and described. 9 weeks
Primary How student absence data can be collected from existing school registration systems. Experiences from collecting data from the individual schools or from the municipalities, on absence per week per class based on the existing absence systems, will be described. 8 weeks
Secondary Response rate of class teachers to the study surveys. Consent will be sought from relevant teachers in part 1 schools, and weekly questionnaires will be sent out. Response rates will be described. Results will be supported by answers to interview questions about motivations and challenges in participating in such surveys. 6 weeks
Secondary Response rate of students/their guardians to study surveys. Consent will be sought from students in part 1 schools, and weekly questionnaires will be sent out. Response rate will be described. 8 weeks
Secondary Proportion of absence due to respiratory disease. Answers to surveys from teachers and students on absence and reasons for absence, from part 1 schools, will be analysed. 8 weeks
Secondary Absence frequency among students Based on the absence data from the schools existing registration systems, we will describe the absence frequency among students in the participating classes. 8 weeks
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