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Clinical Trials in France / NCT05997784
Active, not recruiting Observational

Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing

NCT05997784 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-01-30
Last updated
2025-12-15

Condition(s) studied

Asthma in ChildrenAllergy

Investigational drug(s) / intervention(s)

Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO))Filling of standardized questionnairesUsing an App on a deviceUrine sampleSensors and devices will be used to assess air pollutants in classrooms during the survey

Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)): Performing lung function tests and FeNO following European Respiratory Society (ERS) standardized guidelines, through the MIR portable spirometer and the NIOX Vero®, respectively. Spirometry is performed using a portable spirometer. All manoeuvres are performed according to the American Thoracic Society and European Respiratory Society (ATS/ERS) standards. FeNO test is a quick and non-invasive test that is easy for children to do. To take the test, the child have to blow into a handheld device (NIOX Vero®). More in detail, children are asked to inhale ambient air through a nitrogen oxide scrubber to total lung capacity, and then exhale for 10 seconds. The test results are available right away.

Filling of standardized questionnaires: (Baseline, Follow-up, Quality of life and Final) allowing to collect data on sociodemographic characteristics, health outcomes, potential risk factors, lifestyle and living environment. Health outcomes will consider general health (general status, infections, allergies), respiratory health (asthma symptoms, diagnosis, control, triggers, medications, etc.), perception of health and well-being.

Using an App on a device: Children will have to answer a daily questionnaire on cell phone, tablet, computer...), with the help of parents/caregivers. To encourage children to answer the questions, the questionnaires will be incorporated into a game that will also teach them about environmental challenges and pollutants in Europe. There will be a general health questionnaire with 3 questions assessed on a Likert scale. The application will also include 2 questions on respiratory health, with Yes/No answers. If the answer is Yes to one of the questions, the intensity of symptoms will be assessed on a visual analog scale from 0 to 100 (0 almost no symptoms and 100 the most intense symptoms imaginable).

Urine sample: On a voluntary basis, a urine sample will be collected, as well.

Sensors and devices will be used to assess air pollutants in classrooms during the survey: * Particulate matter (PM) will be assessed with a counter as a well as a remote sensor (Canarin) . * Volatile Organic Compound (VOCs) with a passive sampler (Radiello). * Virus and bacteria will be collected with a pump. The devices will be attached to the classroom wall. In addition, dust pollution will be assessed by collecting dust with a vacuum cleaner in order to assess phthalates (Dimethyl phthalate, diethyl phthalates, Di(2-ethylhexyl) phthalate).

Study summary

The number and types of indoor air pollutants in schools is rising, however little is known about the impact of their potentially synergistic interactions, upon schoolchildren health. Among children, highly susceptible individuals to air pollution include allergy and asthma sufferers, and a low socioeconomic background, however no specific guidance is available.

The Syn-Air-G project will develop a comprehensive and responsive multipollutant monitoring system (in accessible and actionable formats) by constructing and deploying novel but validated and improved sensors of chemical and biological (allergens, microbes) pollutants) and advancing environmentally friendly interventions (including air purifiers). Health: A comprehensive multidisciplinary and exposome approach of health effects of multi-pollution in small children.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Child attending CM1 level at the beginning of the school year * Child in a classroom selected for the project * Child and caregiver(s) willing to follow the study procedures. Exclusion Criteria: Child or child's parents/guardian's who: * Refuse to participate to the project / to give informed consent * Do not want to use the application to fill the questionnaire and follow the protocol procedures. * Do not read or/and write in French * Plan a long stay outside the region that does not allow them to follow the visit plan

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Montpellier Montpellier Occitanie

More University Hospital, Montpellier trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05997784 on ClinicalTrials.gov ↗ ← All trials in France