Effect of Acute Sleep Restriction on Responses to Hypoxia

NCT ID: NCT05563688

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2024-06-30

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.

Conditions

Sleep Deprivation; Hypoxia

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

Hypoxia exposure

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®).

Intervention Type: OTHER

Sleep deprivation

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.

Intervention Type: OTHER

Cognitive tasks

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre FABRIES, MD

Role: CONTACT

pierre.fabries@intradef.gouv.fr

178652089 ext. +33

Facility Contacts

Pierre FABRIES, MD

Role: primary

pierre.fabries@intradef.gouv.fr

178652089 ext. +33

Other Identifiers

2022-A00464-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021PBMD09

Identifier Type: -

Identifier Source: org_study_id