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

Environmental Exposure Clinical Trial

— SynAir-Child  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05105386
• Other study ID #: SEP-210769726
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2027

Study information

• Verified date: October 2021
• Source: National and Kapodistrian University of Athens
• Contact: PARASKEVI XEPAPADAKI, Assoc. Prof.
• Phone: 2132009160
• Email: vickyxepapadaki[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: September 2027
• Est. primary completion date: March 2027
• Gender: All
• Age group: 8 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood
• Childhood Asthma
• Environmental Exposure
• Pollution; Exposure

Intervention

Device:
• SynAir-Child
Monitor the indoor pollutants and their effect on children well being

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Outcome

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