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

9. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in event-based prospective memory accuracy between hypoxia and normoxia conditions
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Direction Centrale du Service de Santé des Armées

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-A00082-49 (Anden identifikator: ANSM)

Plan for individuelle deltagerdata (IPD)

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