Clinical trial NCT06017882: Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
Official title: Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Deprivation
Keywords: acceleration
mental workload
aerospace medicine
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of healthy subjects .

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)
timeFrame: Through study completion (26 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References: