Heat; ExcessChaSPerfNCT05181345
Effect of Sleep Debt on Neurophysiological Responses to Heat Exposure
An observational study of Heat; Excess and Sleep Disorder, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Many people are required to work in stressful situations combining sleep debt and hot environmental conditions. If the effect of sleep debt on cognitive performance is proven, this effect could be increased, during heat exposure, through the deleterious effects of sleep debt on thermoregulatory abilities. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat; Excess, Sleep Disorder
- What is being tested?
- Sleep recording (at home), Heat exposure and Normal sleep
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2022to Feb 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be composed of healthy young male and female.
Who may be able to join
- 18 to 35 years old
- Body Mass Index between 18 and 27 kg/m2
- Body weight ≥ 54 kg
Who cannot join
- Presence or history of medical pathology (cardiological, renal, hepatic, cutaneous, intestinal, neurological...)
- Presence of a significant deviation from the normal values observed on the electrocardiogram
- History of heat stroke
- Known intolerance to heat (e.g. migraine sufferers)
- Presence of a contraindication to blood sampling, notably low venous capital, belonephobia
- Inability to ingest a capsule or refusal of the rectal probe
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- Habitual consumption of caffeine > 500 mg per day
- Alcohol consumption greater than the equivalent of 3 glasses of wine per week
- Consumption of narcotics
- Smoking > 0.5 packet of cigarettes per day
- Undergoing habitual medication
- Pregnant or breastfeeding woman
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-Emmanuel TARDO-DINO, MD, 78651320 ext. +33, pierre-emmanuel.tardo-dino@intradef.gouv.fr
About this study
Many people are required to work in stressful situations combining sleep debt and hot environmental conditions. If the effect of sleep debt on cognitive performance is proven, this effect could be increased, during heat exposure, through the deleterious effects of sleep debt on thermoregulatory abilities. These alterations may favour the occurrence of accidents.
The changes in cognitive performance induced by hyperthermia are also poorly characterised and often not dissociated from the effects of dehydration. Little is known about the effects of the combination of sleep debt and heat exposure on mental performance. Describing and understanding the alterations induced by this combined situation could provide a better understanding of the mechanisms explaining the deterioration of performance in hot conditions and promote the development of appropriate countermeasures.
- Conditions
- Heat; Excess, Sleep Disorder
- Being tested
- Sleep recording (at home), Heat exposure, Normal sleep, Sleep restriction
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep recording (at home)Other
Before both heat exposures, the sleep-wake rhythm will be measured at home for 7 days using actigraphy and a sleep diary that will have been given to him/her during the inclusion visit.
Heat exposureOther
The subjects will be exposed twice (2 different visits) to heat (45°C; 60-70% humidity rate) for 3 hours in a climate chamber.
The subjects will be "equipped" with various external sensors allowing the continuous recording of core temperature, mean skin temperature (9 skin measurement points), heart rate, cerebral electrical activity, cerebral oxygenation, skin vascular conductance (blood flow by laser-doppler), blood pressure and skin conductance.
Neurophysiological and cognitive exploration (NPCE) includes the Stroop test, the Psychomotor Vigilance Task (PVT) and the odd-ball test.
Normal sleepOther
The night before one of the two heat exposures (first visit for the "Normal sleep first" group and second visit for the "Reduced sleep first" group), the participants will have a normal night at home. The duration and quality of sleep will be measured using a connected headband (Dreem®) allowing for polysomnography.
Sleep restrictionOther
The night before one of the two heat exposures (first visit for the "Reduced sleep first" group and second visit for the "Normal sleep first" group), the participants' sleep will be restricted. The sleep restriction will correspond to a reduced sleep period with a bedtime of 3 hours (04:00 - 07:00). This night of sleep restriction will be carried out in a sleep apartment (at the lab). The duration and quality of sleep will be measured using a connected headband (Dreem®) allowing for polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Normal sleep first | The night before the first heat exposure, the participants will have a normal night at home.
The night before the second heat exposure, the participants sleep will be restricted to 3 hours in bed. Receives: Other: Sleep recording (at home); Other: Heat exposure; Other: Normal sleep; Other: Sleep restriction | |
| Reduced sleep first | The night before the first heat exposure, the participants sleep will be restricted to 3 hours in bed.
The night before the second heat exposure, the participants will have a normal night at home. Receives: Other: Sleep recording (at home); Other: Heat exposure; Other: Normal sleep; Other: Sleep restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of errors at the Stroop test
Written color names that differ from the color ink they are printed on will be displayed on a computer screen. In the first trial, the participant must say the written word. In the second trial, the participant must name the ink color instead. The higher the number of correct answers, the higher the score.
Measured: Through study completion (25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start14 Jan 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 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 Heat; ExcessStudies 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
- Cross-sectional
- Enrolment
- 20 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
- NCT05181345
- Sponsor's protocol ID
- 2021PBMD05
- Other IDs
- 2021-A02278-33
- Acronym
- ChaSPerf
- Status last verified
- Apr 2023
- First submitted
- 20 Dec 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beauchamps V, Vanneau T, Bourrilhon C, Pontiggia A, Ayounts H, Guillard M, Sauvet F, Malgoyre A, Quiquempoix M, Tardo-Dino PE. EEG markers confirm the arousing effect of moderate hyperthermia in healthy subjects as opposed to sleep restriction. Int J Hyperthermia. 2025 Dec;42(1):2579894. doi: 10.1080/02656736.2025.2579894. Epub 2025 Dec 17.
PubMed 41408716
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Debt on Neurophysiological Responses to Heat Exposure
- ClinicalTrials.gov ID
- NCT05181345
- Acronym / sponsor ID
- ChaSPerf / 2021PBMD05
- Conditions
- Heat; Excess, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 6 Jan 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.
Many people are required to work in stressful situations combining sleep debt and hot environmental conditions. If the effect of sleep debt on cognitive performance is proven, this effect could be increased, during heat exposure, through the deleterious effects of sleep debt on thermoregulatory abilities. These alterations may favour the occurrence of accidents.
The changes in cognitive performance induced by hyperthermia are also poorly characterised and often not dissociated from the effects of dehydration. Little is known about the effects of the combination of sleep debt and heat exposure on mental performance. Describing and understanding the alterations induced by this combined situation could provide a better understanding of the mechanisms explaining the deterioration of performance in hot conditions and promote the development of appropriate countermeasures.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal sleep first | – | Other: Sleep recording (at home), Other: Heat exposure, Other: Normal sleep, Other: Sleep restrictionThe night before the first heat exposure, the participants will have a normal night at home. The night before the second heat exposure, the participants sleep will be restricted to 3 hours in bed. |
| Reduced sleep first | – | Other: Sleep recording (at home), Other: Heat exposure, Other: Normal sleep, Other: Sleep restrictionThe night before the first heat exposure, the participants sleep will be restricted to 3 hours in bed. The night before the second heat exposure, the participants will have a normal night at home. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be composed of healthy young male and female.
Key inclusion criteria (3 listed)
- 18 to 35 years old
- Body Mass Index between 18 and 27 kg/m2
- Body weight ≥ 54 kg
Key exclusion criteria (12 listed)
- Presence or history of medical pathology (cardiological, renal, hepatic, cutaneous, intestinal, neurological...)
- Presence of a significant deviation from the normal values observed on the electrocardiogram
- History of heat stroke
- Known intolerance to heat (e.g. migraine sufferers)
- Presence of a contraindication to blood sampling, notably low venous capital, belonephobia
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 |
|---|---|---|
| Sleep recording (at home)Before both heat exposures, the sleep-wake rhythm will be measured at home for 7 days using actigraphy and a sleep diary that will have been given to him/her during the inclusion visit. | Other | Normal sleep first, Reduced sleep first |
| Heat exposureThe subjects will be exposed twice (2 different visits) to heat (45°C; 60-70% humidity rate) for 3 hours in a climate chamber. The subjects will be "equipped" with various external sensors allowing the continuous recording of core temperature, mean skin temperature (9 skin measurement points), heart rate, cerebral electrical activity, cerebral oxygenation, skin vascular conductance (blood flow by laser-doppler), blood pressure and skin conductance. Neurophysiological and cognitive exploration (NPCE) includes the Stroop test, the Psychomotor Vigilance Task (PVT) and the odd-ball test. | Other | Normal sleep first, Reduced sleep first |
| Normal sleepThe night before one of the two heat exposures (first visit for the "Normal sleep first" group and second visit for the "Reduced sleep first" group), the participants will have a normal night at home. The duration and quality of sleep will be measured using a connected headband (Dreem®) allowing for polysomnography. | Other | Normal sleep first, Reduced sleep first |
| Sleep restrictionThe night before one of the two heat exposures (first visit for the "Reduced sleep first" group and second visit for the "Normal sleep first" group), the participants' sleep will be restricted. The sleep restriction will correspond to a reduced sleep period with a bedtime of 3 hours (04:00 - 07:00). This night of sleep restriction will be carried out in a sleep apartment (at the lab). The duration and quality of sleep will be measured using a connected headband (Dreem®) allowing for polysomnography. | Other | Normal sleep first, Reduced sleep first |
Primary outcome
Number of errors at the Stroop test
Time frame: Through study completion (25 months)
Written color names that differ from the color ink they are printed on will be displayed on a computer screen. In the first trial, the participant must say the written word. In the second trial, the participant must name the ink color instead. The higher the number of correct answers, the higher the score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 41408716Beauchamps V, Vanneau T, Bourrilhon C, Pontiggia A, Ayounts H, Guillard M, Sauvet F, Malgoyre A, Quiquempoix M, Tardo-Dino PE. EEG markers confirm the arousing effect of moderate hyperthermia in healthy subjects as opposed to sleep restriction. Int J Hyperthermia. 2025 Dec;42(1):2579894. doi: 10.1080/02656736.2025.2579894. Epub 2025 Dec 17.
- Individual participant dataSharing planned: Undecided
Related trials for Heat; Excess
Recruiting
Heat Adaptation Through Community-based Approaches and Research at SEACO: Structural and Behavioural Interventions (Heat Care)
Climate Change, Heat; Weather
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 Heat; Excess and Sleep Disorder, 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 3 inclusion and 12 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 28 Apr 2023. 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-Emmanuel TARDO-DINO, MD (178651320 ext. +33, pierre-emmanuel.tardo-dino@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of errors at the Stroop test (time frame: Through study completion (25 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 NCT05181345, 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 28 Apr 2023.