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TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06372054
Enrollment
200
Registered
2024-04-17
Start date
2024-02-05
Completion date
2027-02-05
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Discogenic Pain, Epigenetic Changes, LONGEVITY 1, Neuroplasticity, NGS, Oxidative Injury, Space Maintenance, Stress Physiological

Keywords

pilots, air force, epigenetic change, environmental exposure

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.

Interventions

OTHERBiological sample collection

Collection of biological samples (blood, urine, saliva) and clinical data

Sponsors

University of Milan
CollaboratorOTHER
Italian Air Force
CollaboratorUNKNOWN
A-Tono
CollaboratorUNKNOWN
Ministry of Defense, Italy
CollaboratorUNKNOWN
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
26 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of flight-related exposure data and molecular modificationsThrough study completion, an average of 3 yearCollection 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

MeasureTime frameDescription
Assessment of General HealthThrough study completion, an average of 3 yearRecording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)
Assessment of Sleep QualityThrough study completion, an average of 3 yearRecording of sleep quality by the Sleeping Quality Questionnaire (SQQ)
Assessment of eating habitsThrough study completion, an average of 3 yearRecording of eating habits by Food Frequency Questionnaire (EPIC)
Creation of reliable AI and disease-based models for personalized medicineThrough study completion, an average of 3 yearIntegration 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

Countries

Italy

Contacts

Primary ContactGiovanni Marfia, MD, PhD
giovanni.marfia@policlinico.mi.it0256660100
Backup ContactLaura Guarnaccia, PhD
laura.guarnaccia@policlinico.mi.it0255034268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026