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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

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

Treatments

Other: Biological sample collection

Study type

Observational

Funder types

Other

Identifiers

NCT06372054
TORNADO

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

26 to 38 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

High-performance Italian Air Force Pilots
Description:
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
Treatment:
Other: Biological sample collection
Italian Air Force ground staff
Description:
This cohort of Italian Air Force ground personnel will be used as a control group to compare data from the pilot cohort.
Treatment:
Other: Biological sample collection

Trial contacts and locations

1

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Central trial contact

Laura Guarnaccia, PhD; Giovanni Marfia, MD, PhD

Data sourced from clinicaltrials.gov

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