Sleep DeprivationHypSomNCT05563688
Effect of Acute Sleep Restriction on Responses to Hypoxia
An observational study of Sleep Deprivation and Hypoxia, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Hypoxia
- What is being tested?
- Hypoxia exposure, Sleep deprivation and Cognitive tasks
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2022to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study population will be composed of healthy active young men.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Pierre FABRIES, MD, 178652089 ext. +33, pierre.fabries@intradef.gouv.fr
About this study
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.
Read more
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
- Being tested
- Hypoxia exposure, Sleep deprivation, Cognitive tasks
- Medical subject headings
- Sleep Deprivation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia exposureOther
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 deprivationOther
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 tasksBehavioural
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (20.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start26 Oct 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563688
- Sponsor's protocol ID
- 2021PBMD09
- Other IDs
- 2022-A00464-39
- Acronym
- HypSom
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Apr;277:109251. doi: 10.1016/j.cmpb.2026.109251. Epub 2026 Jan 14.
PubMed 41576780
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Sleep Restriction on Responses to Hypoxia
- ClinicalTrials.gov ID
- NCT05563688
- Acronym / sponsor ID
- HypSom / 2021PBMD09
- Conditions
- Sleep Deprivation, Hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be composed of healthy active young men.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxia exposureEach 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®). | Other | – |
| Sleep deprivationEach 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. | Other | – |
| Cognitive tasksParticipants 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). | Behavioural | – |
Primary outcome
Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Derived from this study: PubMed 41576780Pontiggia 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 Apr;277:109251. doi: 10.1016/j.cmpb.2026.109251. Epub 2026 Jan 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation and Hypoxia, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre FABRIES, MD (178652089 ext. +33, pierre.fabries@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure. (time frame: Through study completion (20.5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.