- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07585227
Study of the Effects of Acute Exposure to Moderate Altitude Hypoxia on Prospective Memory. (HYPRO)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Carine MALLE, PhD
- 전화번호: 33 178651479
- 이메일: carine.malle@gmail.com
연구 연락처 백업
- 이름: Fabien SAUVET, MD, PhD
- 이메일: fabien.sauvet@gmail.com
연구 장소
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Brétigny-sur-Orge, 프랑스, 91220
- Institut de Recherche Biomédicale des Armées
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연락하다:
- Fabien SAUVET, MD, PhD
- 이메일: fabien.sauvet@gmail.com
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연락하다:
- Carine MALLE, Phd
- 이메일: carine.malle@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Normoxia-Air + Hypoxia-Air
S1 = Normoxia exposure + air administration S2 = Hypoxia exposure + air administration
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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.
|
|
실험적: 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.
|
|
실험적: 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
|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in event-based prospective memory accuracy between hypoxia and normoxia conditions
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-A00082-49 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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