跳至主要内容
临床试验/NCT06372054
NCT06372054招募中不适用

Integration of Omics-based Technologies and Artificial Intelligence to Identify Predictive Risk Models in a Air Force's Pilot Cohort for the Maintenance of Safety, Well-being, Health, and Performance to be Translated to Civil Population

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Assessment of flight-related exposure data and molecular modifications

研究概览

简要总结

The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine.

详细描述

The high-performance pilots of the Italian Air Force are "super healthy" individuals subjected to particular working conditions, as changes in temperature, pressure, gravity, acceleration, exposure to cosmic rays and radiation, which determine psycho-physical adaptation mechanisms to maintain homeostasis. However, this environmental exposure may potentially affect human health, well-being and performance.

The study aims to collect exposure data, clinical, physiological data through biosensors and molecular parameters (at different time point), to be integrated by an Artificial Intelligence algorithm expressly trained to create reliable risk models.

The final outcome will consist of the identification of significant biomarkers of pathological risk, in order to better understand the etiopathological mechanisms of many human diseases and apply early and personalized countermeasures to maintain and empower workers' health status and performance, avoiding clinical symptom presentation.

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
26 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being part of the Italian Air Force, as in active flight service or ground staff
  • Age between 26 and 38 years
  • Consent to collect biological samples and use the wearable device to monitor exposure parameters

排除标准

  • Age < 25 years and > 39 years
  • no signature on informed consent

结局指标

主要结局

Assessment of flight-related exposure data and molecular modifications

时间窗: Through study completion, an average of 3 year

Collection of information on: i) lifestyle, ii) medical examination, iii) previous trauma, iv) cumulative professional exposure to flying, determination of panel of genes and circulating markers to assess prognostic and predictive factors

次要结局

  • Assessment of General Health(Through study completion, an average of 3 year)
  • Assessment of Sleep Quality(Through study completion, an average of 3 year)
  • Assessment of eating habits(Through study completion, an average of 3 year)
  • Creation of reliable AI and disease-based models for personalized medicine(Through study completion, an average of 3 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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