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临床试验/NCT05105386
NCT05105386尚未招募不适用

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

National and Kapodistrian University of Athens0 个研究点目标入组 3,000 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
主要终点
Oxidative stress

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Oxidative stress

时间窗: One year

DNA damage levels in blood cells

Lung function and

时间窗: One year

Spirometry

Immune health

时间窗: One year

RNA Sequency/CRP

Airway inflammation

时间窗: One year

Exhaled nitric oxide

Respiratory, mental health

时间窗: One year

Questionnaires

Exhaled volatile compounds

时间窗: One year

Breath biopsy

Cardiovascular metrics

时间窗: One year

Wearables

Height and weight

时间窗: One year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NIKOLAOS G. PAPADOPOULOS

PROFESSOR

National and Kapodistrian University of Athens

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