Cognitive LoadSiMuCCoDéNCT05081544
Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load
An observational study of Cognitive Load, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Load
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of healthy volunteers from several French infantry regiments (group leaders).
Who may be able to join
- be a group leader in an infantry regiment,
- be over 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Julie ALBENTOSA, PhD, 178651217 ext. +33, julie.albentosa@intradef.gouv.fr
About this study
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.
- Conditions
- Cognitive Load
- Keywords
- cognitive load
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At enrollment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start16 May 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive LoadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081544
- Sponsor's protocol ID
- 2021PBMD01
- Other IDs
- 2021-A00733-38
- Acronym
- SiMuCCoDé
- Status last verified
- Sep 2023
- First submitted
- 7 Oct 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load
- ClinicalTrials.gov ID
- NCT05081544
- Acronym / sponsor ID
- SiMuCCoDé / 2021PBMD01
- Conditions
- Cognitive Load
- Keywords
- cognitive load
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of healthy volunteers from several French infantry regiments (group leaders).
Key inclusion criteria (2 listed)
- be a group leader in an infantry regiment,
- be over 18 years old.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive load level
Time frame: At enrollment (Day 1)
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Load, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie ALBENTOSA, PhD (178651217 ext. +33, julie.albentosa@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive load level (time frame: At enrollment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.