NCT05081544

Brief Summary

The increased complexity of the dismounted combatant's equipment can result in a strain on the various senses (e.g., visual, auditory) that can exceed an individual's limited information processing abilities. The combatant may thus be cognitively overloaded in multi-tasking operational situations. There has been a great deal of research conducted on cognitive load. A battery of multitasking tests has been developed in the field of aeronautics, but, to our knowledge, no measurement of cognitive load specifically dedicated to combatants has been conducted yet.

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 May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

October 7, 2021

Last Update Submit

September 11, 2023

Conditions

Cognitive Load

Keywords

cognitive load

Outcome Measures

Primary Outcomes (1)

  • Cognitive load level

    Cognitive load level will be measured using NASA-TLX questionnaire. NASA-TLX questionnaire comprises 6 dimensions (mental demands, physical demands, time demands, performance, effort and frustration). Each dimension has a score ranging from 0 (low cognitive load) to 100 (high cognitive load), except for the "performance" dimension, whose score ranges from 0 (good performance) to 100 (low performance).

    At enrollment (Day 1)

Eligibility Criteria

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

The study population will be composed of healthy volunteers from several French infantry regiments (group leaders).

You may qualify if:

  • be a group leader in an infantry regiment,
  • be over 18 years old.

You may not qualify if:

  • be a woman,
  • have a heart condition,
  • have a visual disease not corrected by glasses or contact lenses,
  • have a hearing score ≥ 2 on the SIGYCOP,
  • have a psychiatric disorder, a progressive neurological or organic disease requiring drug treatment,
  • take psychotropic drugs,
  • take more than 28 units of alcohol per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

RECRUITING

Central Study Contacts

Julie ALBENTOSA, PhD

CONTACT

178651217julie.albentosa@intradef.gouv.fr

Study Design

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

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 18, 2021

Study Start

May 16, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

FR(1)