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NCT Number: NCT06372054

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

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.

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Key information

Age range

26 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy

Milan, 20139, Italy

Location status: Recruiting

Location contact

Giovanni Marfia, MD, PhD

PRINCIPAL_INVESTIGATOR

Laura Begani, MSc

SUB_INVESTIGATOR

Laura Fontana, PhD

SUB_INVESTIGATOR

Laura Guarnaccia, PhD

SUB_INVESTIGATOR

Luisella Vigna, MD, PhD

SUB_INVESTIGATOR

Matteo Bonzini, MD, PhD

SUB_INVESTIGATOR

Monica R Miozzo, PhD

SUB_INVESTIGATOR

Orazio Granato, PhD

SUB_INVESTIGATOR

Silvana Pileggi, PhD

SUB_INVESTIGATOR

Stefania E Navone, PhD

CONTACT

[email protected]

0256660100 ext. +39

Stefania E Navone, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological sample collection

Other

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

Primary outcomes

  1. 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

  1. Assessment of General Health

    Time frame: Through study completion, an average of 3 year

    Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)

  2. Assessment of Sleep Quality

    Time frame: Through study completion, an average of 3 year

    Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)

  3. Assessment of eating habits

    Time frame: Through study completion, an average of 3 year

    Recording of eating habits by Food Frequency Questionnaire (EPIC)

  4. Creation of reliable AI and disease-based models for personalized medicine

    Time frame: Through study completion, an average of 3 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Marfia, MD, PhD

CONTACT

[email protected]

0256660100 ext. +39

Laura Guarnaccia, PhD

CONTACT

[email protected]

0255034268 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • A-Tono
  • Italian Air Force
  • Ministry of Defense, Italy
  • University of Milan

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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