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

Sleep Deprivation Clinical Trial

— CogPhyAero  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017882
• Other study ID #: 2023PBMD06
• Secondary ID: 2023-A01101-44
• Status: Recruiting
• Start date: September 11, 2023
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Sauvet
• Phone: 178651275
• Email: fabien.sauvet[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Partial sleep deprivation

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)