The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing

Not yet recruiting

• Conditions: Childhood Asthma; Pollution; Exposure; Environmental Exposure; Childhood

• Registration Number: NCT05105386
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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. 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 Timeline

• Study First Submitted: 2021-09-13
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Study Start: 2023-09
• Primary Completion: 2027-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Students of primary schools aged 8-9 years.
2. The subject and/or legal custodian have the verbal, writing and mental ability to understand the intent and character of the study.
3. Written informed consent from the child's parents/guardian's

Exclusion Criteria

Unwilling to use the application and follow the procedures of the protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune health	One year	RNA Sequency/CRP
Oxidative stress	One year	DNA damage levels in blood cells
Lung function and	One year	Spirometry
Airway inflammation	One year	Exhaled nitric oxide
Respiratory, mental health	One year	Questionnaires
Exhaled volatile compounds	One year	Breath biopsy
Cardiovascular metrics	One year	Wearables
Height and weight	One year	Height in cm and weight in kg will be combined to report BMI (kg/m\^2)