Attention Deficit Hyperactivity DisorderNeuroSmogNCT04574414
Determining the Impact of Air Pollution on the Developing Brain
An observational study of Attention Deficit Hyperactivity Disorder and Attention, run by Jagiellonian University at 1 site in Poland.
Trial summary
Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air… Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Attention, Executive Functioning
- What is being tested?
- Psychological testing and MRI imaging
- How many people
- 800 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Observational
- 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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: 800 children aged 10-13 will be sampled to the NeuroSmog study. Both ADHD cases and population controls will be enrolled, two control per case. Cases will be recruited in specialized facilities and controls will be randomly sampled in randomly selected 30 primary schools across 19 big and small towns in Lesser Poland, Silesian and Opole voivodeships in the southern Poland.
Who may be able to join
- Attending school in one of the specified towns
- Age 10-13 years (4th-6th grade)
- Native Polish speaker
- Normal or above intelligence
- Standard educational opportunities
- Normal or corrected to normal visual and auditory acuity
- No gross sensory deficit, no gross behavioural problems
- No history of neurological disease
Who cannot join
- Autism spectrum disorder (ASD)
- FAS
- FAE
- Intellectual disability
- Metabolic disorders
- Genetic disorders
Show all 14Show fewer
- Epilepsy
- Cerebral palsy
- Mood disorders
- Tourette Syndrome
- Other illnesses including pharmacotherapy
- Apgar score < 8
- Low birth weight (below 2500 g)
- Preterm birth (below 35th weeks of gestation)
Trial locations and contacts
1 site in 1 country.
Iana Markevych, PhD contact
About this study
Official title: NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain
- Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. The investigators aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution.
- Study area: 19 towns in three voivodeships (Lesser Poland, Silesian, Opole) in the southern Poland. To reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in PM levels without too high logistic costs, towns were selected by size (big and small) and by PM levels (high, medium and low).
- Design: Case-control study with 800 children recruited over two school years, with two population controls per one ADHD case. Suspected cases will be recruited in specialized facilities and presumably ADHD-free children will be recruited in primary schools.
- Exposure assessment: Poland-wide PM and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from Polish monitoring network. Prenatal, early-life, lifelong and concurrent exposures will be calculated.
- Psychological testing: Every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility.
- Neuroimaging: Each participant will undergo a Magnetic Resonance Imaging (MRI) scanning session that will be performed accordingly to the Human Connectome Adolescent Brain Cognitive Development project recommendations. Scanning will be performed on a single scanner in Krakow.
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention, Executive Functioning, Social Functioning
- Being tested
- Psychological testing and MRI imaging
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological testing and MRI imagingDiagnostic test
Every child will have three sessions with psychologists and be diagnosed as having or not having ADHD.
Every child will be invited to Krakow to undergo MRI measurements, including resting-state and event-related functional MRI, Diffusion Tensor Imaging (DTI), and T1/T2 structural MRI.
| Study group | Role | What they receive |
|---|---|---|
| Children with Attention Deficit Hyperactivity Disorder | Cases Receives: Diagnostic Test: Psychological testing and MRI imaging | |
| Children without Attention Deficit Hyperactivity Disorder | Population controls Receives: Diagnostic Test: Psychological testing and MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder (ADHD)
ADHD and comorbidities will be assessed by Conners 3 questionnaire
Measured: October 1, 2020 until December 31, 2022
Cognitive functioning
Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)
Measured: October 1, 2020 until December 31, 2022
Attention control
Attention Network Test (ANT) will be used.
Measured: October 1, 2020 until December 31, 2022
Sustained and selective attention
Computer Conners Continuous Performance Task (CPT) will be used.
Measured: October 1, 2020 until December 31, 2022
Inhibition control
Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements.
Measured: October 1, 2020 until December 31, 2022
Inhibition control
Go/No Go task will be used as part of MRI measurements.
Measured: October 1, 2020 until December 31, 2022
Secondary outcomes (5)
Full-Scale Intelligence Quotient (IQ)
IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5).
Measured: October 1, 2020 until December 31, 2022
Family functioning
Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning).
Measured: October 1, 2020 until December 31, 2022
Relationships with siblings
Siblings Relationship Questionnaire (KRR), which is a supplement for the SOR Scale will be used to assess social functioning of the children (relationships with siblings).
Measured: October 1, 2020 until December 31, 2022
Behavioural, emotional, and social problems
Youth Self-Report Scale (YSR) will be used for this assessment.
Measured: October 1, 2020 until December 31, 2022
Behavioural problems
Child Behaviour Checklist (CBCL) questionnaire will collect information on the eight syndrome domains: anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour
Measured: October 1, 2020 until December 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Environmental Protection - National Research Institute (IOS-PIB), Foundation for Polish Science
- Responsible party
- Principal investigator, Marcin Szwed, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574414
- Sponsor's protocol ID
- KE_24042019A
- Acronym
- NeuroSmog
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sitnik-Warchulska K, Izydorczyk B, Sawicki A, Markevych I, Szwed M, Lipowska M. A Dyadic Perspective on ADHD: Adolescent-Parent Reports of Behavioural Problems and Family Functioning. Clin Psychol Psychother. 2026 Jan-Feb;33(1):e70230. doi: 10.1002/cpp.70230.
PubMed 41603676Compa M, Walczak B, Baumbach C, Kolodziejczyk J, Mysak Y, Lipowska M, Izydorczyk B, Sitnik-Warchulska K, Markevych I, Szwed M. Association of Socioeconomic Status With IQ and Attention in School Children in Poland, a Country With Relatively Low Socioeconomic Differences. Dev Psychobiol. 2025 Jul;67(4):e70058. doi: 10.1002/dev.70058.
PubMed 40534211
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain
- ClinicalTrials.gov ID
- NCT04574414
- Acronym / sponsor ID
- NeuroSmog / KE_24042019A
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention, Executive Functioning, Social Functioning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Institute of Environmental Protection - National Research Institute (IOS-PIB), Foundation for Polish Science
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Oct 2020 (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.
- Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. The investigators aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution.
- Study area: 19 towns in three voivodeships (Lesser Poland, Silesian, Opole) in the southern Poland. To reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in PM levels without too high logistic costs, towns were selected by size (big and small) and by PM levels (high, medium and low).
- Design: Case-control study with 800 children recruited over two school years, with two population controls per one ADHD case. Suspected cases will be recruited in specialized facilities and presumably ADHD-free children will be recruited in primary schools.
- Exposure assessment: Poland-wide PM and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from Polish monitoring network. Prenatal, early-life, lifelong and concurrent exposures will be calculated.
- Psychological testing: Every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility.
- Neuroimaging: Each participant will undergo a Magnetic Resonance Imaging (MRI) scanning session that will be performed accordingly to the Human Connectome Adolescent Brain Cognitive Development project recommendations. Scanning will be performed on a single scanner in Krakow.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Attention Deficit Hyperactivity Disorder | – | Diagnostic Test: Psychological testing and MRI imagingCases |
| Children without Attention Deficit Hyperactivity Disorder | – | Diagnostic Test: Psychological testing and MRI imagingPopulation controls |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 800 children aged 10-13 will be sampled to the NeuroSmog study. Both ADHD cases and population controls will be enrolled, two control per case. Cases will be recruited in specialized facilities and controls will be randomly sampled in randomly selected 30 primary schools across 19 big and small towns in Lesser Poland, Silesian and Opole voivodeships in the southern Poland.
Key inclusion criteria (8 listed)
- Attending school in one of the specified towns
- Age 10-13 years (4th-6th grade)
- Native Polish speaker
- Normal or above intelligence
- Standard educational opportunities
Key exclusion criteria (14 listed)
- Autism spectrum disorder (ASD)
- FAS
- FAE
- Intellectual disability
- Metabolic disorders
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 |
|---|---|---|
| Psychological testing and MRI imagingEvery child will have three sessions with psychologists and be diagnosed as having or not having ADHD. Every child will be invited to Krakow to undergo MRI measurements, including resting-state and event-related functional MRI, Diffusion Tensor Imaging (DTI), and T1/T2 structural MRI. | Diagnostic test | Children with Attention Deficit Hyperactivity Disorder, Children without Attention Deficit Hyperactivity Disorder |
Primary outcome
Attention Deficit Hyperactivity Disorder (ADHD)
Time frame: October 1, 2020 until December 31, 2022
ADHD and comorbidities will be assessed by Conners 3 questionnaire
Cognitive functioning
Time frame: October 1, 2020 until December 31, 2022
Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)
Attention control
Time frame: October 1, 2020 until December 31, 2022
Attention Network Test (ANT) will be used.
Sustained and selective attention
Time frame: October 1, 2020 until December 31, 2022
Computer Conners Continuous Performance Task (CPT) will be used.
Inhibition control
Time frame: October 1, 2020 until December 31, 2022
Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements.
Inhibition control
Time frame: October 1, 2020 until December 31, 2022
Go/No Go task will be used as part of MRI measurements.
5 secondary outcomes
Full-Scale Intelligence Quotient (IQ)
Time frame: October 1, 2020 until December 31, 2022
Family functioning
Time frame: October 1, 2020 until December 31, 2022
Relationships with siblings
Time frame: October 1, 2020 until December 31, 2022
Behavioural, emotional, and social problems
Time frame: October 1, 2020 until December 31, 2022
Behavioural problems
Time frame: October 1, 2020 until December 31, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 41603676Sitnik-Warchulska K, Izydorczyk B, Sawicki A, Markevych I, Szwed M, Lipowska M. A Dyadic Perspective on ADHD: Adolescent-Parent Reports of Behavioural Problems and Family Functioning. Clin Psychol Psychother. 2026 Jan-Feb;33(1):e70230. doi: 10.1002/cpp.70230.
- Derived from this study: PubMed 40534211Compa M, Walczak B, Baumbach C, Kolodziejczyk J, Mysak Y, Lipowska M, Izydorczyk B, Sitnik-Warchulska K, Markevych I, Szwed M. Association of Socioeconomic Status With IQ and Attention in School Children in Poland, a Country With Relatively Low Socioeconomic Differences. Dev Psychobiol. 2025 Jul;67(4):e70058. doi: 10.1002/dev.70058.
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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.
Iana Markevych, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Attention, run by Jagiellonian University at 1 site in Poland.
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 8 inclusion and 14 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 5 Oct 2020. 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 Poland. 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. 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 Marcin Szwed, Dr. hab. (12 663 24 40 ext. +48, m.szwed@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention Deficit Hyperactivity Disorder (ADHD) (time frame: October 1, 2020 until December 31, 2022). The study lists 6 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 NCT04574414, which also lists 2 linked publications.
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 5 Oct 2020.