Effect of Acute Sleep Restriction on Responses to Hypoxia

NCT05563688 | Unknown

• 2 other identifiers: 2021PBMD092022-A00464-39
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion (20.5 months)

Interventions

Hypoxia exposure OTHER

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®).

Sleep deprivation OTHER

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.

Cognitive tasks BEHAVIORAL

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).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of healthy active young men.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

RECRUITING

Related Publications (1)

• Pontiggia A, Quiquempoix M, Fabries P, Beauchamps V, Jacques C, Guillard M, Van Beers P, Malle C, Gomez-Merino D, Koulmann N, Chennaoui M, Sauvet F; HYPSOM Investigator Group. Robust multimodal mental workload classification: A cross-physiological condition machine learning approach. Comput Methods Programs Biomed. 2026 Jan 14;277:109251. doi: 10.1016/j.cmpb.2026.109251. Online ahead of print.

  PMID: 41576780 DERIVED

MeSH Terms

Conditions

Sleep Deprivation; Hypoxia

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms, Respiratory

Central Study Contacts

Pierre FABRIES, MD

CONTACT

178652089; pierre.fabries@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 3, 2022
• Study Start: October 26, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

FR (1)