Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing (SynAIR-G)
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ClinicalTrials.gov Identifier: NCT05997784 |
Recruitment Status :
Not yet recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Asthma in Children Allergy | Other: Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)) Other: Filling of standardized questionnaires Other: Using an App on a device Other: Urine sample Other: Sensors and devices will be used to assess air pollutants in classrooms during the survey |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Disrupting Noxious Synergies of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing, Using Advanced Intelligent Multisensing |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | September 1, 2025 |
Estimated Study Completion Date : | September 1, 2026 |
- Other: 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.
- Other: 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.
- Other: 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).
- Other: Urine sample
On a voluntary basis, a urine sample will be collected, as well.
- Other: 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).
- Indoor classroom air concentrations of Pollutants and dust [ Time Frame: For 10 Months ]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.
- Prevalence for respiratory disease [ Time Frame: For 10 Months ]
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)
- Association between asthma and indoor air contaminants [ Time Frame: For 10 Months ]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.
- prevalence of children presenting airways obstruction [ Time Frame: Between baseline and 10 Months ]In children, the severity of airway obstruction can be graded according to Forced expiratory volume in one second (FEV1) measured by spirometry, percentage predicted measured by spirometry: FEV1 <100% to 80% indicates mild obstruction in children; FEV1 <80% to 50% indicates moderate obstruction; FEV1 <50% to 30% indicates severe airway obstruction; and FEV1 <30% indicates very severe obstruction.
- Prevalence of children with an abnormal FeNO [ Time Frame: Between baseline and 10 Months ]
Percentages of children with an abnormal FeNO. In clinical practice, a normal FeNO test in children is any number less than 20 parts per billion (ppb) in patients without lung inflammation.
The FeNO will be measured with a handheld device (NIOX Vero®).
- Quality of life and wellbeing [ Time Frame: At 10 months ]General health outcomes will be measured with the use of a subset of questions from the Child Health Questionnaire (CHD) with 13 items, height (centimeter) and weight (kilogram) Quality of life will be measured with the validated Pediatric Quality of Life (PedsQL) questionnaire composed of 23 items and score on a reverse scale of 100 points. ("Never") = 100 = better quality of life, ("Almost Never") = 75("Sometimes") = 50("Often") = 25 ("Almost Always") = 0 = worst quality of life.
- diagnosis of any disease and respiratory diseases [ Time Frame: At 10 months ]General health confirmed by questionnaire and physicians based diagnosis VAS Questionnaire on the app Through Quality of life and wellbeing questionnaires based on validated International Study of Asthma and Allergies in Childhood (ISAAC), PreDicta respiratory, ACT, ACQ
- Environmental source of pollutants [ Time Frame: Baseline ]Children and their caregivers will answer standardized questionnaires on sources and exposures of pollutant. (qualitative questionnaire, no scoring)
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05997784
Contact: Davide CAIMMI, MD | +33467336107 | dp-caimmi@chu-montpellier.fr |
France | |
University Hospital of Montpellier | |
Montpellier, Occitanie, France, 34295 | |
Contact: Davide P CAIMMI, MD,PHD +33467 336 107 |
Study Director: | Davide CAIMMI, CAIMMI | CHU de Montpellier |
Responsible Party: | University Hospital, Montpellier |
ClinicalTrials.gov Identifier: | NCT05997784 |
Other Study ID Numbers: |
RECHMPL23_0206 |
First Posted: | August 18, 2023 Key Record Dates |
Last Update Posted: | August 18, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Air pollution Asthma Allergy Epidemiology |
Public health App Remote sensors |
Hypersensitivity Immune System Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |