An observational study in Oxidative Injury, Stress Physiological and Discogenic Pain, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 26 Years to 38 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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.
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.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 232 studies on the registry; 83 are open to participants now.
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The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The primary study cohort is represented by "super-healthy" high-performance Italian Air Force Pilots, aged between 26 and 38 years, in active flight service. Intervention: not applicable
Other: Biological sample collection
This cohort of Italian Air Force ground personnel will be used as a control group to compare data from the pilot cohort.
Other: Biological sample collection
Collection of biological samples (blood, urine, saliva) and clinical data
Assessment of flight-related exposure data and molecular modifications
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
Time frame: Through study completion, an average of 3 year
Assessment of General Health
Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)
Time frame: Through study completion, an average of 3 year
Assessment of Sleep Quality
Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)
Time frame: Through study completion, an average of 3 year
Assessment of eating habits
Recording of eating habits by Food Frequency Questionnaire (EPIC)
Time frame: Through study completion, an average of 3 year
Creation of reliable AI and disease-based models for personalized medicine
Integration of information obtained from anamnesis, questionnaires, biochemical, genomic, epigenomic, proteomic data with the measurement of heart rate, oxygenation, acceleration, external temperature, presence of ultrasound, infrasound and radiation with artificial intelligence algorithm for the creation of reliable models of disease based on personalized medicine
Time frame: Through study completion, an average of 3 year
Plan to share: No — Subject's data will be collected in completely anonymized form.
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