Effect of Acute Sleep Restriction on Responses to Hypoxia (HypSom)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Sleep Deprivation
• Intervention / Treatment: Other: Hypoxia exposure; Other: Sleep deprivation; Behavioral: Cognitive tasks

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Pierre FABRIES, MD; Phone Number: +33 178652089; Email: pierre.fabries@intradef.gouv.fr

Study Locations

• France
  • Brétigny-sur-Orge, France, 91223
    • Recruiting
    • Institut de recherche biomédicale des armées
    • Contact: Pierre FABRIES, MD; Phone Number: +33 178652089; Email: pierre.fabries@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms, Respiratory; Sleep Deprivation; Hypoxia
• Other Study ID Numbers: 2021PBMD09; 2022-A00464-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No