Clinical trial NCT05563688: Effect of Acute Sleep Restriction on Responses to Hypoxia
Official title: Effect of Acute Sleep Restriction on Responses to Hypoxia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Deprivation
Hypoxia
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of healthy active young men.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male
* Healthy
* Between 18 and 45
* Smoking \< 5 cigarettes per day or nicotine-free electronic cigarette
* Having regular physical activity (between 1 and 4 hours of physical activity per week)
* Affiliated or entitled to a social security plan
* No contraindication to physical exercise
* Having given their consent

Exclusion Criteria:

* Female
* BMI \> 30
* Active medical pathology (cardiological, renal, hepatic, cutaneous, neurological, etc.),
* History of active pathology of less than 6 months
* Significant deviation with the normal values observed during the interrogation, clinical examination or electrocardiogram
* Having spent time at altitude (\> 3500 m) during the last 3 months
* Absolute or relative contraindication to a stay at high altitude
* Medical contraindication to sport practice
* Skin allergy to modified ethanol or capsaicin
* Wearing a pacemaker or ferromagnetic implants
* Poor venous capital
* Pittsburgh Sleep Quality Index Questionnaire \> 5
* Usual sleep duration \< 6 hours
* Not covered by a health insurance plan

Primary outcomes:
measure: Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure.
timeFrame: Through study completion (20.5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References: