Exposure to Polluted AirNCT05111678
Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants
An observational study of Exposure to Polluted Air, run by Turku University Hospital at 1 site in Finland.
Trial summary
To evaluate neurological findings with TSPO-PET and MRI in patients who have been exposed to indoor air pollutants and have potentially neurological symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exposure to Polluted Air
- How many people
- 35 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2021to 31 Mar 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will recruit 50 patients who have been exposed to indoor air pollutants and have possibly neurological symptoms. For comparison the study will recruit also 50 patients with neurological symptoms due to a possible adverse external exposure and who have not been exposed to indoor air pollutants. Additionally, 25 healthy controls will be included.
Who may be able to join
- All:
- Signing the informed consent form
- Adults over 18 years of age
- Indoor air pollutant groups:
- Exposed to indoor air pollutants
- Neurological symptoms
Show all 10Show fewer
- Neurological symptoms groups:
- Neurological symptoms possibly due to adverse external exposure
- Healthy controls:
- Reported healthy person
Who cannot join
- All:
- Pregnancy or breast-feeding
- Corticosteroid treatment within 4 weeks of imaging
- Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
- Contraindication to PET scan and MRI investigations
- Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
Show all 9Show fewer
- Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
- Neurological symptoms groups and healthy controls:
- Exposure to indoor air pollutants
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate neurological findings with TSPO-PET and MRI in patients who have been exposed to indoor air pollutants and have potentially neurological symptoms.
Read the detailed description
Health problems related to indoor air pollutants have been studied for several decades but there is still not sufficient scientific evidence to prove the association between many of the described symptoms and exposure to mold and other air pollutants.
This research aims on studying the activation of microglia and inflammation in the brains of individuals exposed to indoor air pollutants having neurological symptoms with MRI and TSPO-PET imaging, questionnaires and biomarkers and compare the findings to individuals having neurological conditions without exposure to indoor air pollutants as well as healthy controls.
- Conditions
- Exposure to Polluted Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indoor air pollutant groups | 50 patients that have been exposed to indoor air pollutants | |
| Neurological symptoms groups | 50 patients with neurological symptoms possibly due to adverse external exposure without any exposure to indoor air pollutants | |
| Healthy controls | 25 healthy age- and gender-matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
[11C]PK11195 binding in the brain
Change in microglial activity in the brains of the individuals in different study groups as measured by [11C]PK11195 PET imaging
Measured: Baseline
Secondary outcomes (6)
DTI-MRI metrics
To evaluate the microstructural damage of the brain between individuals in different groups
Measured: Baseline
Results from questionnaires
Questionnaires about quality of life compared between the indoor air pollutant and neurological symptoms groups
Measured: Baseline
Blood biomarkers
Biomarkers measured from blood to assess the possible inflammatory state of individuals in different study groups
Measured: Baseline
Neurography measures
Done additionally if clinical studies indicate necessary, to assess the state of peripheral nerves
Measured: Baseline
Electromyography measures
Done additionally if clinical studies indicate necessary, rating each examined muscle as normal/myopathic/neuropathic
Measured: Baseline
Cerebrospinal fluid biomarkers
Biomarkers measured from cerebrospinal fluid to assess the possible inflammatory state of individuals in different study groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Polluted AirStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Airas, MD,Professor, Principal investigator, Turku University Hospital, division of clinical neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111678
- Sponsor's protocol ID
- 1/2021
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants
- ClinicalTrials.gov ID
- NCT05111678
- Acronym / sponsor ID
- 1/2021
- Conditions
- Exposure to Polluted Air
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 8 Nov 2021 (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.
To evaluate neurological findings with TSPO-PET and MRI in patients who have been exposed to indoor air pollutants and have potentially neurological symptoms.
Detailed description
Health problems related to indoor air pollutants have been studied for several decades but there is still not sufficient scientific evidence to prove the association between many of the described symptoms and exposure to mold and other air pollutants.
This research aims on studying the activation of microglia and inflammation in the brains of individuals exposed to indoor air pollutants having neurological symptoms with MRI and TSPO-PET imaging, questionnaires and biomarkers and compare the findings to individuals having neurological conditions without exposure to indoor air pollutants as well as healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indoor air pollutant groups | – | –50 patients that have been exposed to indoor air pollutants |
| Neurological symptoms groups | – | –50 patients with neurological symptoms possibly due to adverse external exposure without any exposure to indoor air pollutants |
| Healthy controls | – | –25 healthy age- and gender-matched controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 50 patients who have been exposed to indoor air pollutants and have possibly neurological symptoms. For comparison the study will recruit also 50 patients with neurological symptoms due to a possible adverse external exposure and who have not been exposed to indoor air pollutants. Additionally, 25 healthy controls will be included.
Key inclusion criteria (10 listed)
- Signing the informed consent form
- Adults over 18 years of age
- Exposed to indoor air pollutants
- Neurological symptoms
- Neurological symptoms possibly due to adverse external exposure
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding
- Corticosteroid treatment within 4 weeks of imaging
- Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
- Contraindication to PET scan and MRI investigations
- Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
[11C]PK11195 binding in the brain
Time frame: Baseline
Change in microglial activity in the brains of the individuals in different study groups as measured by [11C]PK11195 PET imaging
6 secondary outcomes
DTI-MRI metrics
Time frame: Baseline
Results from questionnaires
Time frame: Baseline
Blood biomarkers
Time frame: Baseline
Neurography measures
Time frame: Baseline
Electromyography measures
Time frame: Baseline
Cerebrospinal fluid biomarkers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Laura Airas, MD,Professor principal investigator
Turku University Hospital, division of clinical neurosciences
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 Exposure to Polluted Air, run by Turku University Hospital at 1 site in Finland.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 10 Apr 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[11C]PK11195 binding in the brain (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.