Clinical trial NCT03978026: Vigilance and Simulated Driving After a Nap
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Nap
vigilance
cognition
driving simulation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: driving performances
timeFrame: baseline
measure: sleepiness (vigilance)
timeFrame: baseline
measure: fatigue (vigilance)
timeFrame: baseline
measure: motor coordination (vigilance)
timeFrame: baseline
Secondary outcomes:
measure: sleep
timeFrame: baseline
measure: temperature
timeFrame: baseline
measure: heart rate
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: PFRS
Study officials:
affiliation: UMR 1075 COMETE
name: Antoine Gauthier
role: STUDY_CHAIR
References: