HypSom: Effect of Acute Sleep Restriction on Responses to Hypoxia

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Recruiting
CT.gov ID
NCT05563688
Collaborator
(none)
25
1
19.2
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypoxia exposure
  • Other: Sleep deprivation
  • Behavioral: Cognitive tasks

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Effect of Acute Sleep Restriction on Responses to Hypoxia
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure. [Through study completion (20.5 months)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge France 91223

Sponsors and Collaborators

  • Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT05563688
Other Study ID Numbers:
  • 2021PBMD09
  • 2022-A00464-39
First Posted:
Oct 3, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2022