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

NCT05997784 | Active Not Recruiting

• 1 other identifier: RECHMPL23_0206
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergy; Asthma in Children

Keywords

Air pollution; Asthma; Allergy; Epidemiology; Public health; App; Remote sensors

Outcome Measures

Primary Outcomes (3)

• Indoor classroom air concentrations of Pollutants and dust

  Classrooms concentrations (mean with standard deviation SD) of Viruses, Microbe, Allergens, Chemical Air Pollutants (particulate mater PM , NO2, VOCs, phthalates) (ppm part per million) in air and dust.

  For 10 Months

• Prevalence for respiratory disease

  Health outcomes measures by the prevalence (%) for allergic and respiratory health reported physician-based diagnosis of asthma and/or allergies. Questionnaires about respiratory health disease based on validated International Study of Asthma and Allergies in Childhood (ISAAC) and PreDicta respiratory * Asthma Control Test (ACT) composed of 7 items with a Score 20 to 25 means a well-controlled asthma, Score 15 - 19: partially controlled asthma and a Score \< 15 means an uncontrolled asthma * Asthma control questionnaire (ACQ) composed of 7 items and Scores range between 0 (totally controlled asthma) and 6 (severely uncontrolled).) * Visual Analogic Scale (VAS) Questionnaire on the App (a score of 0 no symptoms and 100 the most respiratory symptoms)

  For 10 Months

• Association between asthma and indoor air contaminants

  Significant association of indoor air quality contaminants and their interactions with health outcomes in schoolchildren: odds-ratio and 95% confidence interval between active asthma and indoor air total Volatile Organic Compound (VOCs) and dust phthalates.

  For 10 Months

Secondary Outcomes (5)

• prevalence of children presenting airways obstruction

  Between baseline and 10 Months

• Prevalence of children with an abnormal FeNO

  Between baseline and 10 Months

• Quality of life and wellbeing

  At 10 months

• diagnosis of any disease and respiratory diseases

  At 10 months

• Environmental source of pollutants

  Baseline

Interventions

Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)) OTHER

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.

Using an App on a device OTHER

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 OTHER

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 OTHER

* 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).

Filling of standardized questionnaires OTHER

(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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A maximum of 500 schoolchildren at CM1 level (French education system), equally distributed between males and females, will derive from a maximum of eight primary schools and 2-3 classes of CM1 in each school, when available. Therefore, two-three classrooms per schools, in no more than 8 schools, each year, over 2 consecutive school years will be monitored, and children will be followed-up during 10 months. The selection of schools will be based on socioeconomic and air pollution criteria (differences between different regions of the participating centres) and whenever possible on annual reports on air quality (if available) from the respectively Directorate of Climate Change and Atmospheric Quality of the Ministry of Environment.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tbilisi State Medical University: collaborator
• University of Oulu: collaborator
• University Hospital, Montpellier: lead
• National and Kapodistrian University of Athens: collaborator
• University of Manchester: collaborator

Study Sites (1)

University Hospital of Montpellier

Montpellier, Occitanie, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Hypersensitivity; Asthma; Alzheimer Disease

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Davide CAIMMI, CAIMMI

  CHU de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: August 18, 2023
• Study Start: January 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-07

Locations

FR (1)