Pollution; ExposureSynAir-ChildNCT05105386
The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing
An observational study of Pollution; Exposure and Environmental Exposure, run by National and Kapodistrian University of Athens.
Trial summary
To quantify health effects of synergizing chemical and biological pollutants in a targeted population setting, i.e., school-aged children. Indoor air pollutants will be monitored within the classrooms with high end sensors. Exposure data from additional sources (outdoor, home, transports) will be obtained. Read more about this study
- Who is it for?
- Ages 8 to 9 years
- Conditions the study is for
- Pollution; Exposure, Environmental Exposure, Childhood Asthma
- What is being tested?
- SynAir-Child
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 9 years
- All sexes
- Child
Study population: Children at this age have the ability to understand the character of the study, to handle the app and the wearables, to successfully perform lung function and airway inflammation measurements (as it has been ascertained in the previous FP7_PreDicta and Horizon_CURE projects), to cooperate with blood sampling, while not being yet subjective to hormonal changes of puberty. Moreover, students at this age mainly attend lessons in the same class, thus exposures in the school environment are considered stable,
Who may be able to join
- Students of primary schools aged 8-9 years.
- The subject and/or legal custodian have the verbal, writing and mental ability to understand the intent and character of the study.
- Written informed consent from the child's parents/guardian's
Who cannot join
- Unwilling to use the application and follow the procedures of the protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To quantify health effects of synergizing chemical and biological pollutants in a targeted population setting, i.e., school-aged children. Indoor air pollutants will be monitored within the classrooms with high end sensors. Exposure data from additional sources (outdoor, home, transports) will be obtained. Health outcomes will be assessed prospectively using validated medical procedures and real-time tracking with mobile health (mHealth) equipment and a gamified computer app.
Read the detailed description
Communication with individual schools and families representing diverse cultural and socioeconomic backgrounds, will be conducted and formal participation consents obtained. The target population will include healthy children and be enriched for children with respiratory allergies and asthma. Provision of instructions, training for participation and baseline assessments of respiratory, immune, and mental health using questionnaires and relevant physiological measurements (e.g spirometry, FeNO), will be performed. Sensors will be positioned and cross-checked for functionality.Health data from the cohort will be monitored by a specifically designed gamified application, as well as by state-of-the-art wearable tracking technology. The app will capture input from the participants at large, while the trackers will accurately, continuously, and remotely, identify personalized patterns of all day activity status, heart rate, oxygen saturation, temperature, blood pressure, sleep, respiratory rate, and mechano-acoustic breathing sounds signatures. Sentinel data will be processed in Work Package 6 and integrated in the SynAir-G autonomous sensing platform.
Children will be prospectively followed-up for a school year. Investigators will regularly visit schools to keep sensors running and collect materials. Real-time tracking will be coupled with regular communication and face-to-face visits for health outcome assessments. Devices will be positioned in selected locations. The cohort will also provide the setting for establishing indoor and outdoor interactions, dose-responses in real life, and health outcome data for integration and synergy analyses.
- Being tested
- SynAir-Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynAir-ChildDevice
Monitor the indoor pollutants and their effect on children well being
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory, mental health
Questionnaires
Measured: One year
Immune health
RNA Sequency/CRP
Measured: One year
Oxidative stress
DNA damage levels in blood cells
Measured: One year
Lung function and
Spirometry
Measured: One year
Airway inflammation
Exhaled nitric oxide
Measured: One year
Exhaled volatile compounds
Breath biopsy
Measured: One year
Cardiovascular metrics
Wearables
Measured: One year
Height and weight
Height in cm and weight in kg will be combined to report BMI (kg/m^2)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startSep 2023 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NIKOLAOS G. PAPADOPOULOS, National and Kapodistrian University of Athens
- Investigators
- NIKOLAOS G PAPADOPOULOS, Professor, Study chair, National and Kapodistrian Univeristy of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105386
- Sponsor's protocol ID
- SEP-210769726
- Acronym
- SynAir-Child
- Status last verified
- Oct 2021
- First submitted
- 13 Sep 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing
- ClinicalTrials.gov ID
- NCT05105386
- Acronym / sponsor ID
- SynAir-Child / SEP-210769726
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 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 quantify health effects of synergizing chemical and biological pollutants in a targeted population setting, i.e., school-aged children. Indoor air pollutants will be monitored within the classrooms with high end sensors. Exposure data from additional sources (outdoor, home, transports) will be obtained. Health outcomes will be assessed prospectively using validated medical procedures and real-time tracking with mobile health (mHealth) equipment and a gamified computer app.
Detailed description
Communication with individual schools and families representing diverse cultural and socioeconomic backgrounds, will be conducted and formal participation consents obtained. The target population will include healthy children and be enriched for children with respiratory allergies and asthma. Provision of instructions, training for participation and baseline assessments of respiratory, immune, and mental health using questionnaires and relevant physiological measurements (e.g spirometry, FeNO), will be performed. Sensors will be positioned and cross-checked for functionality.Health data from the cohort will be monitored by a specifically designed gamified application, as well as by state-of-the-art wearable tracking technology. The app will capture input from the participants at large, while the trackers will accurately, continuously, and remotely, identify personalized patterns of all day activity status, heart rate, oxygen saturation, temperature, blood pressure, sleep, respiratory rate, and mechano-acoustic breathing sounds signatures. Sentinel data will be processed in Work Package 6 and integrated in the SynAir-G autonomous sensing platform.
Children will be prospectively followed-up for a school year. Investigators will regularly visit schools to keep sensors running and collect materials. Real-time tracking will be coupled with regular communication and face-to-face visits for health outcome assessments. Devices will be positioned in selected locations. The cohort will also provide the setting for establishing indoor and outdoor interactions, dose-responses in real life, and health outcome data for integration and synergy analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Age groups
- Child
- Study population
- Children at this age have the ability to understand the character of the study, to handle the app and the wearables, to successfully perform lung function and airway inflammation measurements (as it has been ascertained in the previous FP7_PreDicta and Horizon_CURE projects), to cooperate with blood sampling, while not being yet subjective to hormonal changes of puberty. Moreover, students at this age mainly attend lessons in the same class, thus exposures in the school environment are considered stable,
Key inclusion criteria (3 listed)
- Students of primary schools aged 8-9 years.
- The subject and/or legal custodian have the verbal, writing and mental ability to understand the intent and character of the study.
- Written informed consent from the child's parents/guardian's
Key exclusion criteria (1 listed)
- Unwilling to use the application and follow the procedures of the protocol
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 |
|---|---|---|
| SynAir-ChildMonitor the indoor pollutants and their effect on children well being | Device | – |
Primary outcome
Respiratory, mental health
Time frame: One year
Questionnaires
Immune health
Time frame: One year
RNA Sequency/CRP
Oxidative stress
Time frame: One year
DNA damage levels in blood cells
Lung function and
Time frame: One year
Spirometry
Airway inflammation
Time frame: One year
Exhaled nitric oxide
Exhaled volatile compounds
Time frame: One year
Breath biopsy
Cardiovascular metrics
Time frame: One year
Wearables
Height and weight
Time frame: One year
Height in cm and weight in kg will be combined to report BMI (kg/m^2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Pollution; Exposure
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Voices Illuminating Solutions for Outdoor Workers' Needs and Safety
Air Pollution Exposure
Active, not recruiting
Effect of an Antioxidant Dietary Supplement on Skin Radiance
Healthy Women
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.
NIKOLAOS G PAPADOPOULOS, Professor study chair
National and Kapodistrian Univeristy of Athens
Questions about this trial
What is this clinical trial studying?
An observational study of Pollution; Exposure and Environmental Exposure, run by National and Kapodistrian University of Athens.
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: opening soon, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PARASKEVI XEPAPADAKI, Assoc. Prof. (2132009160, vickyxepapadaki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory, mental health (time frame: One year). The study lists 8 primary outcomes in all. 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 3 Nov 2021.