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

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06017882
Collaborator
(none)
28
1
26
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Partial sleep deprivation

Study Design

Study Type:
Observational
Anticipated Enrollment :
28 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge France 91223

Sponsors and Collaborators

  • Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT06017882
Other Study ID Numbers:
  • 2023PBMD06
  • 2023-A01101-44
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Direction Centrale du Service de Santé des Armées
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023