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NCT Number: NCT07585227

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91220, France

Location contact

Carine MALLE, Phd

CONTACT

[email protected]

Fabien SAUVET, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxia Exposure

Other

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

Oxygen administration

Drug

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

Air administration

Other

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

Standardized cognitive tests (on a computer)

Behavioral

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

Physiological measurements

Device

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

Blood sample

Biological

A blood sample is collected for mitochondrial breathing analyses

Cognitive tests embedded in a flight simulator scenario

Behavioral

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

Primary outcomes

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carine MALLE, PhD

CONTACT

[email protected]

178651479 ext. 33

Fabien SAUVET, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Official study title

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

Acronym: HYPRO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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