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NCT Number: NCT05105386

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

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.

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Key information

Conditions

Pollution; Exposure Childhood Childhood Asthma Environmental Exposure

Age range

8 year–9 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SynAir-Child

Device

Monitor the indoor pollutants and their effect on children well being

Primary outcomes

  1. Respiratory, mental health

    Time frame: One year

    Questionnaires

  2. Immune health

    Time frame: One year

    RNA Sequency/CRP

  3. Oxidative stress

    Time frame: One year

    DNA damage levels in blood cells

  4. Lung function and

    Time frame: One year

    Spirometry

  5. Airway inflammation

    Time frame: One year

    Exhaled nitric oxide

  6. Exhaled volatile compounds

    Time frame: One year

    Breath biopsy

  7. Cardiovascular metrics

    Time frame: One year

    Wearables

  8. Height and weight

    Time frame: One year

    Height in cm and weight in kg will be combined to report BMI (kg/m^2)

Study contacts

Contact information is provided by the study sponsor or research team.

NIKOLAOS G PAPADOPOULOS, Professor

CONTACT

[email protected]

2107776964

PARASKEVI XEPAPADAKI, Assoc. Prof.

CONTACT

[email protected]

2132009160

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Acronym: SynAir-Child

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2021
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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