Effect of Sleep Debt on Neurophysiological Responses to Heat Exposure

NCT05181345 | Unknown

• 2 other identifiers: 2021PBMD052021-A02278-33
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion (25 months)

Study Arms (2)

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.

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.

Other: Sleep recording (at home); Other: Heat exposure; Other: Normal sleep; Other: Sleep restriction

Interventions

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.

Normal sleep first; Reduced sleep first

Heat exposure OTHER

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 sleep first; Reduced sleep first

Normal sleep OTHER

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.

Normal sleep first; Reduced sleep first

Sleep restriction OTHER

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.

Normal sleep first; Reduced sleep first

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of healthy young male and female.

You may qualify if:

• to 35 years old
• Body Mass Index between 18 and 27 kg/m2
• Body weight ≥ 54 kg

You may not qualify if:

• 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
• 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

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

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Pierre-Emmanuel TARDO-DINO, MD

CONTACT

178651320; pierre-emmanuel.tardo-dino@intradef.gouv.fr

Study Design

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

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 6, 2022
• Study Start: January 14, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (1)