CognitionLEARNNCT06197477
Indoor Air Quality Monitoring and Impact on Children's Health
A study testing OurAir SQ 1750 - Mobile Air Purification System for indoor in people with Cognition, run by Hasselt University at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Cognition
- What is being tested?
- OurAir SQ 1750 - Mobile Air Purification System for indoor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls
- Attending school in the 4th -6th grade in elementary schools included in the study
- Signed informed consent form by legal representative
Who cannot join
- Insufficient knowledge of local language (ie. Dutch, Greek, Danish) by child or parents
Trial locations and contacts
1 site in 1 country.
Nawrot contact
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, 3590
Rossella Alfano
Tim Nawrot
About this study
Official title: 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
Read the 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.
- Conditions
- Cognition
- Being tested
- OurAir SQ 1750 - Mobile Air Purification System for indoor, Sham intervention
- Keywords
- indoor air pollution, indoor air quality, cognition in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OurAir SQ 1750 - Mobile Air Purification System for indoorDevice
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 interventionDevice
Filtration will be turned off in the control part of the study and then will be turned on during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Air purification | Experimental | The intervention will consist of air purification placed in the classrooms. Receives: 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. Receives: Device: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: at the end of the intervention and at the end of the sham intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start20 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Nawrot, Hasselt University
- Investigators
- Tim Nawrot, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197477
- Sponsor's protocol ID
- Hasselt University
- Acronym
- LEARN
- Status last verified
- Jan 2024
- First submitted
- 28 Sep 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berden DP, Chu WK, Alfaro-Moreno E, Gutzke VH, Karakosta C, Kedwell-Simmering K, Kumar V, Massling A, Laursen KR, Scope A, Veeckman C, Alfano R, Vanoirbeek JAJ, Nawrot TS. Environmental, biological and cognitive monitoring of children in European primary schools: LEARN crossover study protocol. Front Public Health. 2026 Jul 2;14:1838168. doi: 10.3389/fpubh.2026.1838168. eCollection 2026.
PubMed 42465630
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Assessments for Indoor Air Quality Monitoring and Impact on Children's Health - Cohorts in Schools & Biomarkers of Exposure
- ClinicalTrials.gov ID
- NCT06197477
- Acronym / sponsor ID
- LEARN / Hasselt University
- Conditions
- Cognition
- Keywords
- indoor air pollution, indoor air quality, cognition in children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air purification | Experimental | Device: OurAir SQ 1750 - Mobile Air Purification System for indoorThe intervention will consist of air purification placed in the classrooms. |
| Control | Sham comparator | Device: Sham interventionFiltration will be turned off in the air purifier placed in the classrooms in the control part of the study. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boys and girls
- Attending school in the 4th -6th grade in elementary schools included in the study
- Signed informed consent form by legal representative
Key exclusion criteria (1 listed)
- Insufficient knowledge of local language (ie. Dutch, Greek, Danish) by child or parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OurAir SQ 1750 - Mobile Air Purification System for indoorFiltration 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. | Device | Air purification |
| Sham interventionFiltration will be turned off in the control part of the study and then will be turned on during the intervention. | Device | Control |
Primary outcome
Change in Correct Detection of continuous Performance Test
Time frame: at the end of the intervention and at the end of the sham intervention
Change in the number of times the child responded correctly to the target alphanumeric stimulus. Higher rates of correct detections indicate better attentional capacity.
Change in the number of correct substitutions of Symbol Digit Modalities Test
Time frame: at the end of the intervention and at the end of the sham intervention
Change in the the number of correct substitutions the child performed. Higher number of correct substitutions indicate better information processing ability.
Change in the Memory Span Task score
Time frame: at the end of the intervention and at the end of the sham intervention
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
Change in the Signal Detection Test score
Time frame: at the end of the intervention and at the end of the sham intervention
Change in the number of correct detection of signals. Higher rates of correct detection indicate better perception ability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 42465630Berden DP, Chu WK, Alfaro-Moreno E, Gutzke VH, Karakosta C, Kedwell-Simmering K, Kumar V, Massling A, Laursen KR, Scope A, Veeckman C, Alfano R, Vanoirbeek JAJ, Nawrot TS. Environmental, biological and cognitive monitoring of children in European primary schools: LEARN crossover study protocol. Front Public Health. 2026 Jul 2;14:1838168. doi: 10.3389/fpubh.2026.1838168. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nawrot contact
Tim Nawrot, PhD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OurAir SQ 1750 - Mobile Air Purification System for indoor in people with Cognition, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rossella Alfano, PhD (+3281739400, rossella.alfano@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Correct Detection of continuous Performance Test (time frame: at the end of the intervention and at the end of the sham intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.