Sleep DeprivationCogPhyAeroNCT06017882
Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
An observational study of Sleep Deprivation, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Partial sleep deprivation
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2023to Nov 2025
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is composed of healthy subjects .
Who may be able to join
- Healthy subject (male or female);
- Tobacco consumption < 5 cigarettes per day or nicotine-free vapour;
- Regular physical activity (between 1 and 8 hours per week);
- Affiliated or entitled to a social security scheme;
- Having given their consent.
Who cannot join
- Presenting an active medical pathology or a history <6 months (cardiological, renal, hepatic, cutaneous, neurological, psychiatric...), or a significant deviation from normal values observed during questioning, clinical examination or electrocardiogram (ECG);
- BMI > 30 (cardiovascular risk factor);
- Have a medical contraindication to sporting activities;
- Taking a medical treatment;
- Habitual sleep duration < 6 hours;
- Presenting a sleep disorder confirmed by questionnaire (Pittsburgh Sleep Quality Index Questionnaire > 5);
- Pregnant or breastfeeding
- Not covered by a health insurance plan;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Fabien SAUVET, MD, PhD, 178651275 ext. +33, fabien.sauvet@intradef.gouv.fr
Anaïs PONTIGGIA, anais.pontiggia@intradef.gouv.fr
About this study
Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex).
The main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct.
Read more
Moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance.
The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.
- Conditions
- Sleep Deprivation
- Being tested
- Partial sleep deprivation
- Keywords
- acceleration, mental workload, aerospace medicine
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial sleep deprivationOther
| Study group | Role | What they receive |
|---|---|---|
| Group A : Usual sleep *2 ; Deprivation *2 | V1->V3 id. V4 : Usual sleep and test series (easy; difficult; difficult) V5 : Usual sleep and test series (difficult; easy; easy) V6 : Sleep deprivation and test series (easy; easy; difficult) V7 : Sleep deprivation and test series (difficult; difficult; easy) Receives: Other: Partial sleep deprivation | |
| Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep | V1->V3 id. V4 : Usual sleep and test series ( difficult; difficult ; easy) V5 : Sleep deprivation and test series (easy; difficult; difficult) V6 : Sleep deprivation and test series (difficult; easy; easy) V7 : Usual sleep and test series (easy ; easy ; difficult) Receives: Other: Partial sleep deprivation | |
| Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep | V1->V3 id. V4 : Sleep deprivation and test series (easy; easy; difficult) V5 : Usual sleep and test series (difficult; difficult; easy) V6 : Sleep deprivation and test series (easy; difficult; difficult) V7 : Usual and test series (difficult; easy; easy) Receives: Other: Partial sleep deprivation | |
| Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep | V1->V3 id. V4 : Sleep deprivation and test series (difficult; easy; easy) V5 : Sleep deprivation and test series (easy; difficult; easy) V6 : Usual sleep and test series ( difficult; easy ; easy) V7 : Usual sleep and test series (easy ; difficult; difficult) Receives: Other: Partial sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)
MATB-II (Multi Attribute Task Battery) is a complex task simulator that mimics realistic tasks commonly performed by aircraft pilots during flight. Among these tasks, target tracking involves positioning a reticle at the center of the simulator's artificial horizon. The variance of the reticle's position as a function of the acceleration received in the centrifuge will be the primary outcome mesure in this study. This is a quantitative measure provided by the simulator.
Measured: Through study completion (26 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start11 Sep 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 28 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
- NCT06017882
- Sponsor's protocol ID
- 2023PBMD06
- Other IDs
- 2023-A01101-44
- Acronym
- CogPhyAero
- Status last verified
- Oct 2023
- First submitted
- 11 Aug 2023
- Last updated
- 27 Oct 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
- ClinicalTrials.gov ID
- NCT06017882
- Acronym / sponsor ID
- CogPhyAero / 2023PBMD06
- Conditions
- Sleep Deprivation
- Keywords
- acceleration, mental workload, aerospace medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 30 Aug 2023 (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.
Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex).
The main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct.
Moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance.
The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A : Usual sleep *2 ; Deprivation *2 | – | Other: Partial sleep deprivationV1->V3 id. V4 : Usual sleep and test series (easy; difficult; difficult) V5 : Usual sleep and test series (difficult; easy; easy) V6 : Sleep deprivation and test series (easy; easy; difficult) V7 : Sleep deprivation and test series (difficult; difficult; easy) |
| Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep | – | Other: Partial sleep deprivationV1->V3 id. V4 : Usual sleep and test series ( difficult; difficult ; easy) V5 : Sleep deprivation and test series (easy; difficult; difficult) V6 : Sleep deprivation and test series (difficult; easy; easy) V7 : Usual sleep and test series (easy ; easy ; difficult) |
| Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep | – | Other: Partial sleep deprivationV1->V3 id. V4 : Sleep deprivation and test series (easy; easy; difficult) V5 : Usual sleep and test series (difficult; difficult; easy) V6 : Sleep deprivation and test series (easy; difficult; difficult) V7 : Usual and test series (difficult; easy; easy) |
| Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep | – | Other: Partial sleep deprivationV1->V3 id. V4 : Sleep deprivation and test series (difficult; easy; easy) V5 : Sleep deprivation and test series (easy; difficult; easy) V6 : Usual sleep and test series ( difficult; easy ; easy) V7 : Usual sleep and test series (easy ; difficult; difficult) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is composed of healthy subjects .
Key inclusion criteria (5 listed)
- Healthy subject (male or female);
- Tobacco consumption < 5 cigarettes per day or nicotine-free vapour;
- Regular physical activity (between 1 and 8 hours per week);
- Affiliated or entitled to a social security scheme;
- Having given their consent.
Key exclusion criteria (8 listed)
- Presenting an active medical pathology or a history <6 months (cardiological, renal, hepatic, cutaneous, neurological, psychiatric...), or a significant deviation from normal values observed during questioning, clinical examination or electrocardiogram (ECG);
- BMI > 30 (cardiovascular risk factor);
- Have a medical contraindication to sporting activities;
- Taking a medical treatment;
- Habitual sleep duration < 6 hours;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial sleep deprivation | Other | Group A : Usual sleep *2 ; Deprivation *2, Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep, Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep, Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep |
Primary outcome
Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)
Time frame: Through study completion (26 months)
MATB-II (Multi Attribute Task Battery) is a complex task simulator that mimics realistic tasks commonly performed by aircraft pilots during flight. Among these tasks, target tracking involves positioning a reticle at the center of the simulator's artificial horizon. The variance of the reticle's position as a function of the acceleration received in the centrifuge will be the primary outcome mesure in this study. This is a quantitative measure provided by the simulator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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 Sleep Deprivation, 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 5 inclusion and 8 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 27 Oct 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 Sauvet (178651275 ext. +33, fabien.sauvet@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement) (time frame: Through study completion (26 months)). 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 27 Oct 2023.