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Study of the Effects of Acute Exposure to Moderate Altitude Hypoxia on Prospective Memory. (HYPRO)

9 mei 2026 bijgewerkt door: Direction Centrale du Service de Santé des Armées

Etude Des Effets d'Une Exposition aiguë à l'Hypoxie d'Altitude modérée Sur la mémoire Prospective (HYPRO)

The goal of this study is to investigate whether prospective memory, i.e., memory for delayed intentions, is impaired at moderate altitude (4,000m).

It will also allow to study the effect of air and oxygen administration during hypoxia exposure.

The main questions it aims to answer are:

  • Does moderate acute hypoxia impair prospective memory ?
  • If so, does air or oxygen adminsitration induce a restoration of prospective memory? Researchers will compare cognitive performance during normobaric hypoxia exposure to cognitive performance during normoxia (control situation).

Participants will:

  • Session S0. Perform a battery of neuropsychological tests and questionnaires). EEG will be recorded during tests. A cheek swab will be performed.
  • Sessions S1 and S2. Perform several cognitive tasks while exposed to hypoxia and to normoxia (2 different sessions, randomized order) in a normobaric chamber. These are standardized cognitive tests administered on a computer and cognitive tests embedded in a flight simulator scenario. Various questionnaires will be performed on a regular basis. Several physiological measurements will be performed continuously: EEG, ECG, SpO2 and breathing rate. Blood pressure will be measured at the beginning and at the end of hypoxia/normoxia exposure. A blood sample will also be performed. At last, participants will inhale air or oxygen through a mask while making a cognitive task in the chamber.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Flight crew operate in a dynamic, complex, and uncertain environment that requires them to process a large amount of information from multiple sources under time pressure. To successfully carry out their mission, flight crews must therefore constantly sort, prioritize, and analyze relevant information based on the situation, which requires them to manage their cognitive resources simultaneously-at the risk of experiencing a decline in performance that could significantly compromise aviation safety.

With recent changes in the geostrategic context, the flight profiles of operational missions expose military aircraft crews and onboard operators to a greater risk of in-flight hypoxia. During an acute hypoxic episode, physiological cardiac and respiratory responses are triggered to protect the body-and particularly the brain-from oxygen deprivation. However, these mechanisms are effective only for a limited time. If normoxia is not restored, symptoms will manifest as hypoxemia worsens.

Among flight crew members, impairments in cognitive functions-particularly prospective memory-such as failing to report one's position to other aircraft or failing to retract the flaps before takeoff, are common and can lead to serious accidents. To our knowledge, the effects of hypoxic exposure on this form of memory have not yet been investigated.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Healthy volunteer
  • Has provided informed consent

Exclusion Criteria:

  • Individuals who do not understand French
  • Pregnant or breastfeeding women
  • Cardiovascular risk factor
  • Infectious disease within the last 4 weeks
  • Chronic cardiovascular, respiratory, hematological, neurological, psychiatric, or metabolic disease
  • History of epileptic seizures, convulsions, or loss of consciousness
  • Individuals with migraines
  • History of a bleeding disorder
  • History of high blood pressure
  • Current medication use (excluding contraception)
  • History of episodes of altitude intolerance
  • Stay at high altitude (> 3,500 m) within the last 3 months
  • Anxiety score on the Hospital Anxiety and Depression (HAD) scale > 7
  • Depression score on the HAD scale > 7
  • Uncontrollable claustrophobia or a history of panic attacks

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Normoxia-Air + Hypoxia-Air
S1 = Normoxia exposure + air administration S2 = Hypoxia exposure + air administration
Ander: Hypoxia exposure
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Ander: Air administration
Air administration (Fi02 = 21%) through a mask during 10 minutes
Gedragsmatig: Standardized cognitive tests (on a computer)
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
Apparaat: Physiological measurements
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
Biologisch: Blood sample
A blood sample is collected for mitochondrial breathing analyses
Gedragsmatig: Cognitive tests embedded in a flight simulator scenario
Event-based prospective memory and time-based prospective memory. Prepar3D flight simulator.
Experimenteel: Hypoxia-Air + Normoxia-Air
S1 = Hypoxia exposure + air administration S2 = Normoxia exposure + air administration
Ander: Hypoxia exposure
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Ander: Air administration
Air administration (Fi02 = 21%) through a mask during 10 minutes
Gedragsmatig: Standardized cognitive tests (on a computer)
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
Apparaat: Physiological measurements
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
Biologisch: Blood sample
A blood sample is collected for mitochondrial breathing analyses
Gedragsmatig: Cognitive tests embedded in a flight simulator scenario
Event-based prospective memory and time-based prospective memory. Prepar3D flight simulator.
Experimenteel: Normoxia-O2 + Hypoxia-O2
S1 = Normoxia exposure + oxygen administration S2 = Hypoxia exposure + oxygen administration
Ander: Hypoxia exposure
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Gedragsmatig: Standardized cognitive tests (on a computer)
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
Apparaat: Physiological measurements
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
Biologisch: Blood sample
A blood sample is collected for mitochondrial breathing analyses
Gedragsmatig: Cognitive tests embedded in a flight simulator scenario
Event-based prospective memory and time-based prospective memory. Prepar3D flight simulator.
Geneesmiddel: Oxygen administration
Oxygen administration (FiO2 = 100%) through a mask during 10 minutes
Experimenteel: Hypoxia-O2 + Normoxia-O2
S1 = Hypoxia exposure + oxygen administration S2 = Normoxia exposure + oxygen administration
Ander: Hypoxia exposure
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Gedragsmatig: Standardized cognitive tests (on a computer)
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
Apparaat: Physiological measurements
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
Biologisch: Blood sample
A blood sample is collected for mitochondrial breathing analyses
Gedragsmatig: Cognitive tests embedded in a flight simulator scenario
Event-based prospective memory and time-based prospective memory. Prepar3D flight simulator.
Geneesmiddel: Oxygen administration
Oxygen administration (FiO2 = 100%) through a mask during 10 minutes

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in event-based prospective memory accuracy between hypoxia and normoxia conditions
Tijdsspanne: Through study completion, an average of 1 month
Accuracy (%) = Prospective memory target detection rate (number of targets correctly responded to / total number of targets presented × 100)
Through study completion, an average of 1 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Direction Centrale du Service de Santé des Armées

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

6 mei 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 mei 2026

Eerst geplaatst (Werkelijk)

13 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

9 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-A00082-49 (Andere identificatie: ANSM)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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