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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197477
Other study ID # Hasselt University
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2023
Est. completion date December 2025

Study information

Verified date January 2024
Source Hasselt University
Contact Rossella Alfano, PhD
Phone +3281739400
Email rossella.alfano@uhasselt.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims at understanding the relation between indoor air quality in schools, including both chemical and microbiological determinants, and cognition in children by gathering data across different parts of Europe


Description:

The LEARN project, funded by the European Commission, aims to gain an in-depth understanding about indoor air quality in schools and its impact on children's cognitive development. This involves evaluating school cohorts in three different countries (Belgium, Greece and Denmark). In participating schools, we measure and characterise indoor and outdoor air pollutants and evaluate the presence of exposure biomarkers and their effect on children's cognition. Measuring indoor air quality, exposure and creating remedial strategies are crucial steps to improve air quality in the school environment and ensure the well-being of children.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria: - Boys and girls - Attending school in the 4th -6th grade in elementary schools included in the study - Signed informed consent form by legal representative Exclusion Criteria: - Insufficient knowledge of local language (ie. Dutch, Greek, Danish) by child or parents

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OurAir SQ 1750 - Mobile Air Purification System for indoor
Filtration device will be placed in classrooms. Computational Fluid Dynamics simulations will be used to find optimal position and operation mode for air purification systems in classrooms.
Sham intervention
Filtration will be turned off in the control part of the study and then will be turned on during the intervention.

Locations

Country Name City State
Belgium Hasselt University Diepenbeek

Sponsors (1)

Lead Sponsor Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Correct Detection of continuous Performance Test Change in the number of times the child responded correctly to the target alphanumeric stimulus. Higher rates of correct detections indicate better attentional capacity. at the end of the intervention and at the end of the sham intervention
Primary Change in the number of correct substitutions of Symbol Digit Modalities Test Change in the the number of correct substitutions the child performed. Higher number of correct substitutions indicate better information processing ability. at the end of the intervention and at the end of the sham intervention
Primary Change in the Memory Span Task score Change in the number of longest list of items that a child can repeat back in correct order. Longer list of recalled items indicate better short term memory at the end of the intervention and at the end of the sham intervention
Primary Change in the Signal Detection Test score Change in the number of correct detection of signals. Higher rates of correct detection indicate better perception ability at the end of the intervention and at the end of the sham intervention
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