Clinical trial NCT06374316: Air Purifiers in Classrooms for Infection Control - a Pilot Study
Official title: Air Purifiers in Classrooms for Infection Control - a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Feasibility
Acceptability
Keywords: Infection Control
Air Purifier
Covid-19
School
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: SINTEF Health Research
First posted: 2024-04-18
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will select schools for participation in arm 1 and 2, respectively, based on the feasibility of installing ceiling-mounted and placing portable air purifiers in each relevant classroom. In arm 3, all three classrooms will be equipped with both ceiling-mounted and portable air purifiers, as well as indoor air quality sensors.

For this arm, we will randomize the three classrooms to each of three weekly programs for the air purifiers;

Program 1) Week 1, 4, and 7: Ceiling-mounted ON, Week 2, 5, and 8: No purifier on, Week 3, 6, and 9: Portable ON. Program 2) Week 1, 4, and 7: Portable ON, Week 2, 5, and 8: Ceiling-mounted ON, Week 3, 6, and 9: No purifier on. Program 3) Week 1, 4, and 7: No purifier on Week 2, 5, and 8: Portable ON, Week 3, 6, and 9: Ceiling-mounted ON.

Each classroom will be assigned a computer-generated random number and will based on the ascending order of the random numbers be allocated to the three predetermined sequences of programs.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms.
timeFrame: 9 weeks
measure: Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms.
timeFrame: 9 weeks
measure: Acceptability of having Air Purifiers in Classrooms
timeFrame: 6 weeks
measure: Untoward events when installing air purifiers in classrooms
timeFrame: 2 weeks
measure: Untoward events when running air purifiers in classrooms
timeFrame: 9 weeks
measure: How student absence data can be collected from existing school registration systems.
timeFrame: 8 weeks
Secondary outcomes:
measure: Response rate of class teachers to the study surveys.
timeFrame: 6 weeks
measure: Response rate of students/their guardians to study surveys.
timeFrame: 8 weeks
measure: Proportion of absence due to respiratory disease.
timeFrame: 8 weeks
measure: Absence frequency among students
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
References: