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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05676424
Other study ID # 2021PBMD07
Secondary ID 2022-A01311-42
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date December 2024

Study information

Verified date June 2023
Source Direction Centrale du Service de Santé des Armées
Contact Julie ALBENTOSA, PhD
Phone 178651217
Email julie.albentosa@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To support the landed soldier during operational missions in hostile environment, equipment must be designed to enable soldiers to cope with strong visual, auditory and informational demands. Technological solutions proposed by manufacturers are embodied in increasingly sophisticated systems. These systems take too little account of the characteristics of the perceptive and cognitive skills of human beings in an action situation. Cognitive load results from the interaction between, on the one hand, the characteristics of the task and the constraints it imposes, and on the other hand, the resources available to the individual, in terms of skills, motivation, physiological state and social support. The phenomenon of cognitive overload occurs when the individual no longer has sufficient resources to meet the demands of the task, which leads to a deterioration in his performance which, in high-risk situations, jeopardizes his safety. Tasks are treated differently depending on their level of difficulty. We will base ourselves on Rasmussen's SRK (Skill Rule Knowledge) model, which describes three levels of information processing: level S refers to the (automatic) processing of sensory-motor and cognitive skills, level R refers to the execution of rules and procedures embedded in mental models, and level K refers to the mental activities of elaborating procedures, based on high-level cognitive mechanisms, such as anticipation, evaluation or planning. Multitasking situations are therefore generally composed of tasks of various levels of difficulty which lead to a higher or lower cost of cognitive control. Thus, this study is aimed at identifying variations in the subjective level of cognitive load of landed combatants (group leaders) as a function of the level of difficulty of primary tasks.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - to be a soldier in an infantry regiment, - to be a group leader. Exclusion Criteria: - to be in a situation of motor disability, - to have a cardiac pathology, - to have a visual pathology not corrected by glasses or contact lenses, - to have a hearing impairment, - to have a psychiatric disorder; a progressive neurological or organic pathology requiring drug treatment, - to take psychotropic drugs, - to take more than 28 units of alcohol per week, - to be epileptic.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective level of cognitive load, measured with the National Aeronautics and Space AdministrationTask Load Index (NASA-TLX) The National Aeronautics and Space AdministrationTask Load Index (NASA-TLX) is a widely used, subjective, multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance.
The NASA-TLX score is comprised between 0 and 100 with higher score meaning high level of cognitive load.
Through study completion (12 months)
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