An observational study in Sleep Deprivation and Hypoxia, sponsored by Direction Centrale du Service de Santé des Armées. Status unknown at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by Direction Centrale du Service de Santé des Armées · Observational
At altitude, humans are exposed to environmental hypoxia induced by the decrease in barometric pressure. On duty or in training, mountain troops, paratroopers or aircrew are regularly exposed to altitude. The effects of altitude on humans occur gradually from 1500 m and depend on both the duration of exposure and the altitude level. Cognitive disorders can occur from 3500 m (threshold of disorders) but there is a very large inter-individual variability.
The countermeasure to altitude hypoxia is oxygen but its use is not systematic between 3000 and 4000 m. Its use depends on the duration of exposure, without clearly established standards. Incapacitating effects on the operational capacity and health of soldiers can therefore occur as early as 3500 m.
In operations or during training, altitude exposure is often associated with a significant sleep debt (particularly during night or early morning missions), jet lag or precarious rest conditions in overseas operations. These sleep restrictions promote the degradation of mental performance with effects similar to those observed in hypoxia.
The combination of these constraints induces a physiological stress which can favour alterations in mental performance, an increase in incapacity, intolerance to altitude or the occurrence of altitude-related pathologies in military personnel. This could occur in particular in the operational zone around the threshold of disorders (3500 m) where the indication of oxygen is discussed.
The objective of this study is to assess the impact of acute sleep restriction on hypoxia tolerance.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 48 observational studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 93 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will be composed of healthy active young men.
Exclusion Criteria:
Each participant will be exposed to the hypoxic environment on 2 occasions (one after a normal sleep night and one after sleep deprivation). Each exposure will be for 5 hours at a FiO2 of 13.2% (3500 m simulated altitude). This exposure will be carried out in a normobaric hypoxic tent (Sporting Edge®).
Each participant will be exposed to sleep deprivation on 2 occasions (one before normoxia exposure and one before hypoxia exposure). Each sleep deprivation involves a time spent in bed of 3 hours (03h00 - 06h00). Sleep deprivation will be carried out in a sleep apartment. Sleep duration and quality will be assessed using a sleep headband (Dreem®), actigraphs Actiwatch® and E4 Empatica®) and a sleep diary.
Participants will perform several cognitive tasks in the following conditions: * in normoxia (FiO2 = 21%) after a night of usual sleep (\> 6 hours) ; * in normoxia (FiO2 = 21%) after a night of reduced sleep (3 hours); * in normobaric hypoxia (FiO2 = 13.2%) after a night of normal sleep (\> 6 hours); * in normobaric hypoxia (FiO2 = 13.2%) after a night of reduced sleep (3 hours).
Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure.
PVT-10 is a sustained-attention, reaction-timed task that measures the consistency with which subjects respond to a visual stimulus. The participant sits in front of a computer. He has a screen in front of him with a 4-digit counter (0 at the start). He is instructed to click the left mouse button as fast as possible when the counter starts to scroll. The counter returns to zero when the participant has clicked. Reaction time (in ms) is calculated for each stimulus.
Time frame: Through study completion (20.5 months)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Direction Centrale du Service de Santé des Armées