Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT05105386

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
3,000 (estimated)
Sponsor
National and Kapodistrian University of Athens · Academic / Other
Sex
All
Age
8 Years – 9 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DEVICESynAir-ChildMonitor the indoor pollutants and their effect on children well being

Timeline

Start date
2023-09-01
Primary completion
2027-03-01
Completion
2027-09-01
First posted
2021-11-03
Last updated
2021-11-03

Source: ClinicalTrials.gov record NCT05105386. Inclusion in this directory is not an endorsement.