NCT06197477

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

September 28, 2023

Last Update Submit

January 8, 2024

Conditions

Keywords

indoor air pollutionindoor air qualitycognition in children

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Air purification

EXPERIMENTAL

The intervention will consist of air purification placed in the classrooms.

Device: OurAir SQ 1750 - Mobile Air Purification System for indoor

Control

SHAM COMPARATOR

Filtration will be turned off in the air purifier placed in the classrooms in the control part of the study.

Device: Sham intervention

Interventions

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.

Air purification

Filtration will be turned off in the control part of the study and then will be turned on during the intervention.

Control

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Boys and girls
  • Attending school in the 4th -6th grade in elementary schools included in the study
  • Signed informed consent form by legal representative

You may not qualify if:

  • Insufficient knowledge of local language (ie. Dutch, Greek, Danish) by child or parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

RECRUITING

Study Officials

  • Tim Nawrot, PhD

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rossella Alfano, PhD

CONTACT

Nawrot

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2023

First Posted

January 9, 2024

Study Start

November 20, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations