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Clinical Trials/NCT06372054
NCT06372054
Recruiting
Not Applicable

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 site in 1 country200 target enrollmentFebruary 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxidative Injury
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Enrollment
200
Locations
1
Primary Endpoint
Assessment of flight-related exposure data and molecular modifications
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
February 5, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Assessment of flight-related exposure data and molecular modifications

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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