NCT05676424

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

December 22, 2022

Last Update Submit

June 26, 2023

Conditions

Keywords

cognitive overload

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of healthy soldiers serving as group leaders in an infantry regiment.

You may qualify if:

  • to be a soldier in an infantry regiment,
  • to be a group leader.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Françoise DARSES, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations