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Набор скоро начнётся NCT05105386

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

Наблюдательное Pollution; Exposure Environmental Exposure Childhood Asthma Childhood

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SynAir-Child.
Кому может быть актуально
Состояния в реестре: Pollution; Exposure, Environmental Exposure, Childhood Asthma, Childhood. Базовые параметры: 8 лет — 9 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Respiratory, mental health [Срок оценки: One year]
  • Immune health [Срок оценки: One year]
  • Oxidative stress [Срок оценки: One year]
  • Lung function and [Срок оценки: One year]
  • Airway inflammation [Срок оценки: One year]
  • Exhaled volatile compounds [Срок оценки: One year]
  • Cardiovascular metrics [Срок оценки: One year]
  • Height and weight [Срок оценки: One year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05105386 · SEP-210769726

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗