Vigilance and Simulated Driving After a Nap

Study Overview
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Brief Summary
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The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance. This study also aims to record during nap time, sleep, body temperature and heart rate.

Detailed Description
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Nap time is one of the most effective means of combating decreased alertness throughout the day and maintaining cognitive and psychomotor performance. As such, it is recommended for long-haul drivers driving their vehicle. However, these drivers have no alternative but to sleep in their seats. These conditions are not optimal for producing quality sleep. The motorcyclist, for his part, has no chance of sleeping without finding a place to feel safe to give himself up to sleep. On these bases, SOMBOX has developed a mini-hotel allowing drivers to find an optimized place to take a nap. Investigators propose an experimental study to evaluate the effectiveness, on simulator driving performance and on the results obtained during cognitive and motor testing, of a nap taken under three different conditions. The effect of the nap will be assessed by comparison to a rest awake. This study should include healthy volunteer participants.

Official Title
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Evaluation de l'efficacité Sur la Vigilance et Les Performances de Conduite simulée d'Une Sieste effectuée Dans Des Environnements différents, Dont le Module SOMBOX

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Behavioral: Nap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Male and female participants, aged 20 to 50 years in good health, good sleepers (>8h on average), not being extreme chronotypes, without sleep disorders, healthy, unmedicated, not working in shift work, having been licensed for at least 2 years and driving a minimum of 5000 km per year The need for the collection of the signature of informed consent The need to be affiliated with the social security system The need to understand French Exclusion Criteria: participant with a sleep disorder, even if not medicated participant with extreme morning or evening chronotype pregnancy ill or medicated participant

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participant is evaluated in 4 situations : nap in a bed nap on a car sit nap in the Sombox no nap sitting on a car sit
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nap in a bed<br>the participants take a nap of 30 min in a bed in a bedroom | Behavioral: Nap<br>* Each participant is compared to himself in 4 conditions,<br>|
| Experimental: nap in an armchair<br>the participants take a nap of 30 min in a car sit in a bedroom | Behavioral: Nap<br>* Each participant is compared to himself in 4 conditions,<br>|
| Experimental: nap in teh Sombox<br>the participants take a nap of 30 min in the micro-hotel Sombox | Behavioral: Nap<br>* Each participant is compared to himself in 4 conditions,<br>|
| Sham Comparator: no nap in a bed<br>the participant stay awaked for 30 min in a bed in a bedroom | Behavioral: Nap<br>* Each participant is compared to himself in 4 conditions,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| driving performances | number of lateral deviations of the vehicule | baseline | 
| sleepiness (vigilance) | Psychomotor vigilance test (PVT) | baseline | 
| fatigue (vigilance) | Karolinska Sleepiness Scale (KSS), | baseline | 
| motor coordination (vigilance) | the angle of the steering wheel | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep | (EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2), | baseline | 
| temperature | measured each minute with e-tact medical device | baseline | 
| heart rate |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nap, vigilance, cognition, driving simulation