The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing (SynAir-Child)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Childhood Asthma; Environmental Exposure; Pollution; Exposure; Childhood
• Intervention / Treatment: Device: SynAir-Child

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: PARASKEVI XEPAPADAKI, Assoc. Prof.; Phone Number: 2132009160; Email: vickyxepapadaki@gmail.com
• Study Contact Backup: Name: NIKOLAOS G PAPADOPOULOS, Professor; Phone Number: 2107776964; Email: ngpoffice@allergy.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 9 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children at this age have the ability to understand the character of the study, to handle the app and the wearables, to successfully perform lung function and airway inflammation measurements (as it has been ascertained in the previous FP7_PreDicta and Horizon_CURE projects), to cooperate with blood sampling, while not being yet subjective to hormonal changes of puberty. Moreover, students at this age mainly attend lessons in the same class, thus exposures in the school environment are considered stable,

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Study Chair: NIKOLAOS G PAPADOPOULOS, Professor, National and Kapodistrian Univeristy of Athens

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SEP-210769726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No