NCT07585227

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 30, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 30, 2026

Last Update Submit

May 9, 2026

Conditions

Keywords

prospective memoryworking memoryflight simulator

Outcome Measures

Primary Outcomes (1)

  • Change in event-based prospective memory accuracy between hypoxia and normoxia conditions

    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

Study Arms (4)

Normoxia-Air + Hypoxia-Air

EXPERIMENTAL

S1 = Normoxia exposure + air administration S2 = Hypoxia exposure + air administration

Other: Hypoxia exposureOther: Air administrationBehavioral: Standardized cognitive tests (on a computer)Device: Physiological measurementsBiological: Blood sampleBehavioral: Cognitive tests embedded in a flight simulator scenario

Hypoxia-Air + Normoxia-Air

EXPERIMENTAL

S1 = Hypoxia exposure + air administration S2 = Normoxia exposure + air administration

Other: Hypoxia exposureOther: Air administrationBehavioral: Standardized cognitive tests (on a computer)Device: Physiological measurementsBiological: Blood sampleBehavioral: Cognitive tests embedded in a flight simulator scenario

Normoxia-O2 + Hypoxia-O2

EXPERIMENTAL

S1 = Normoxia exposure + oxygen administration S2 = Hypoxia exposure + oxygen administration

Other: Hypoxia exposureDrug: Oxygen administrationBehavioral: Standardized cognitive tests (on a computer)Device: Physiological measurementsBiological: Blood sampleBehavioral: Cognitive tests embedded in a flight simulator scenario

Hypoxia-O2 + Normoxia-O2

EXPERIMENTAL

S1 = Hypoxia exposure + oxygen administration S2 = Normoxia exposure + oxygen administration

Other: Hypoxia exposureDrug: Oxygen administrationBehavioral: Standardized cognitive tests (on a computer)Device: Physiological measurementsBiological: Blood sampleBehavioral: Cognitive tests embedded in a flight simulator scenario

Interventions

Normobaric hypoxia exposure (FiO2 = 12,6%, equivalent to 4,000m) during 4h

Hypoxia-Air + Normoxia-AirHypoxia-O2 + Normoxia-O2Normoxia-Air + Hypoxia-AirNormoxia-O2 + Hypoxia-O2

Oxygen administration (FiO2 = 100%) through a mask during 10 minutes

Hypoxia-O2 + Normoxia-O2Normoxia-O2 + Hypoxia-O2

Air administration (Fi02 = 21%) through a mask during 10 minutes

Hypoxia-Air + Normoxia-AirNormoxia-Air + Hypoxia-Air

Auditory oddball, visual oddball, event-based prospective memory, time-based prospective memory, n-back.

Hypoxia-Air + Normoxia-AirHypoxia-O2 + Normoxia-O2Normoxia-Air + Hypoxia-AirNormoxia-O2 + Hypoxia-O2

EEG, ECG, SpO2, breathing rate, eyetracking, blood pressure

Hypoxia-Air + Normoxia-AirHypoxia-O2 + Normoxia-O2Normoxia-Air + Hypoxia-AirNormoxia-O2 + Hypoxia-O2
Blood sampleBIOLOGICAL

A blood sample is collected for mitochondrial breathing analyses

Hypoxia-Air + Normoxia-AirHypoxia-O2 + Normoxia-O2Normoxia-Air + Hypoxia-AirNormoxia-O2 + Hypoxia-O2

Event-based prospective memory and time-based prospective memory. Prepar3D flight simulator.

Hypoxia-Air + Normoxia-AirHypoxia-O2 + Normoxia-O2Normoxia-Air + Hypoxia-AirNormoxia-O2 + Hypoxia-O2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer
  • Has provided informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91220, France

Location

MeSH Terms

Conditions

HypoxiaHypoxia, BrainAltitude Sickness

Interventions

OxygenBlood Specimen Collection

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Carine MALLE, PhD

CONTACT

Fabien SAUVET, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized repeated-measures crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 13, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations