Study of the Effects of Acute Exposure to Moderate Altitude Hypoxia on Prospective Memory. (HYPRO)
9. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Carine MALLE, PhD
- Telefonnummer: 33 178651479
- E-post: carine.malle@gmail.com
Studer Kontakt Backup
- Navn: Fabien SAUVET, MD, PhD
- E-post: fabien.sauvet@gmail.com
Studiesteder
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Brétigny-sur-Orge, Frankrike, 91220
- Institut de Recherche Biomédicale des Armées
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Ta kontakt med:
- Fabien SAUVET, MD, PhD
- E-post: fabien.sauvet@gmail.com
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Ta kontakt med:
- Carine MALLE, Phd
- E-post: carine.malle@gmail.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Normoxia-Air + Hypoxia-Air
S1 = Normoxia exposure + air administration S2 = Hypoxia exposure + air administration
|
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Air administration (Fi02 = 21%) through a mask during 10 minutes
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
A blood sample is collected for mitochondrial breathing analyses
Event-based prospective memory and time-based prospective memory.
Prepar3D flight simulator.
|
|
Eksperimentell: Hypoxia-Air + Normoxia-Air
S1 = Hypoxia exposure + air administration S2 = Normoxia exposure + air administration
|
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Air administration (Fi02 = 21%) through a mask during 10 minutes
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
A blood sample is collected for mitochondrial breathing analyses
Event-based prospective memory and time-based prospective memory.
Prepar3D flight simulator.
|
|
Eksperimentell: Normoxia-O2 + Hypoxia-O2
S1 = Normoxia exposure + oxygen administration S2 = Hypoxia exposure + oxygen administration
|
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
A blood sample is collected for mitochondrial breathing analyses
Event-based prospective memory and time-based prospective memory.
Prepar3D flight simulator.
Oxygen administration (FiO2 = 100%) through a mask during 10 minutes
|
|
Eksperimentell: Hypoxia-O2 + Normoxia-O2
S1 = Hypoxia exposure + oxygen administration S2 = Normoxia exposure + oxygen administration
|
Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h
Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.
EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure
A blood sample is collected for mitochondrial breathing analyses
Event-based prospective memory and time-based prospective memory.
Prepar3D flight simulator.
Oxygen administration (FiO2 = 100%) through a mask during 10 minutes
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in event-based prospective memory accuracy between hypoxia and normoxia conditions
Tidsramme: Through study completion, an average of 1 month
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Accuracy (%) = Prospective memory target detection rate (number of targets correctly responded to / total number of targets presented × 100)
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Through study completion, an average of 1 month
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
6. mai 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
9. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Tegn og symptomer, luftveier
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hypoksi
- Hypoksi, hjerne
- Høydesyke
- Undersøkelsesteknikker
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Uorganiske kjemikalier
- Elementer
- Kalkogener
- Gasser
- Oksygen
- Blodprøveinnsamling
Andre studie-ID-numre
- 2026-A00082-49 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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