Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload

NCT06017882 | Unknown

• 2 other identifiers: 2023PBMD062023-A01101-44
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Keywords

acceleration; mental workload; aerospace medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion (26 months)

Study Arms (4)

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)

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)

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)

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)

Other: Partial sleep deprivation

Interventions

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of healthy subjects .

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Sauvet

CONTACT

178651275; fabien.sauvet@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 30, 2023
• Study Start: September 11, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

FR (1)