Indoor Air Quality Monitoring and Impact on Children's Health

Cognition Clinical Trial

— LEARN  

Official title:

Development of Novel Assessments for Indoor Air Quality Monitoring and Impact on Children's Health - Cohorts in Schools & Biomarkers of Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197477
• Other study ID #: Hasselt University
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognition

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