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| Name | Class |
|---|---|
| University of Milan | OTHER |
| Italian Air Force | UNKNOWN |
| A-Tono | UNKNOWN |
| Ministry of Defense, Italy |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-performance Italian Air Force Pilots | 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 |
| |
| Italian Air Force ground staff | This cohort of Italian Air Force ground personnel will be used as a control group to compare data from the pilot cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological sample collection | Other | Collection of biological samples (blood, urine, saliva) and clinical data |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of General Health | Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI) | Through study completion, an average of 3 year |
| Assessment of Sleep Quality |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Marfia, MD, PhD | Contact | 0256660100 | +39 | giovanni.marfia@policlinico.mi.it |
| Laura Guarnaccia, PhD | Contact | 0255034268 | +39 | laura.guarnaccia@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Marfia, MD, PhD | Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force | Principal Investigator |
| Emanuele Garzia, MD, PhD | Italian Air Force | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy | Recruiting | Milan | 20139 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35678198 | Result | Marfia G, Navone SE, Guarnaccia L, Campanella R, Locatelli M, Miozzo M, Perelli P, Della Morte G, Catamo L, Tondo P, Campanella C, Lucertini M, Ciniglio Appiani G, Landolfi A, Garzia E. Space flight and central nervous system: Friends or enemies? Challenges and opportunities for neuroscience and neuro-oncology. J Neurosci Res. 2022 Sep;100(9):1649-1663. doi: 10.1002/jnr.25066. Epub 2022 Jun 9. | |
| 36998982 |
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Subject's data will be collected in completely anonymized form.
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| UNKNOWN |
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Blood, urine, salivae
Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)
| Through study completion, an average of 3 year |
| Assessment of eating habits | Recording of eating habits by Food Frequency Questionnaire (EPIC) | 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 | Through study completion, an average of 3 year |
| Marco Locatelli, MD, PhD |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Study Chair |
| Francesco Vestito, PhD | Italian Air Force | Study Chair |
| Result |
| Marfia G, Guarnaccia L, Navone SE, Ampollini A, Balsamo M, Benelli F, Gaudino C, Garzia E, Fratocchi C, Di Murro C, Ligarotti GK, Campanella C, Landolfi A, Perelli P, Locatelli M, Ciniglio Appiani G. Microgravity and the intervertebral disc: The impact of space conditions on the biomechanics of the spine. Front Physiol. 2023 Mar 14;14:1124991. doi: 10.3389/fphys.2023.1124991. eCollection 2023. |