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

October 26, 2023 updated by: Direction Centrale du Service de Santé des Armées

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of healthy subjects .

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion (26 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PBMD06
  • 2023-A01101-44 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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