Indoor Air Quality Monitoring and Impact on Children's Health (LEARN)

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

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

Study Overview

• Status: Recruiting
• Conditions: Cognition
• Intervention / Treatment: Device: OurAir SQ 1750 - Mobile Air Purification System for indoor; Device: Sham intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rossella Alfano, PhD; Phone Number: +3281739400; Email: rossella.alfano@uhasselt.be
• Study Contact Backup: Name: Nawrot

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Recruiting
    • Hasselt University
    • Contact: Rossella Alfano
    • Principal Investigator: Tim Nawrot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air purification; The intervention will consist of air purification placed in the classrooms.	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 Comparator: Control; Filtration will be turned off in the air purifier placed in the classrooms in the control part of the study.	Device: Sham intervention; Filtration will be turned off in the control part of the study and then will be turned on during the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Tim Nawrot, PhD, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: indoor air pollution; indoor air quality; cognition in children
• Other Study ID Numbers: Hasselt University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No