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Vigilance and Simulated Driving After a Nap

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03978026
Acronym
SOMBOX
Enrollment
40
Registered
2019-06-06
Start date
2019-05-01
Completion date
2019-12-30
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Nap, vigilance, cognition, driving simulation

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.

Interventions

BEHAVIORALNap

Each participant is compared to himself in 4 conditions,

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Masking description

Participants will be recorded by technicians and results stored anonymously for traitement

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
driving performancesbaselinenumber of lateral deviations of the vehicule
sleepiness (vigilance)baselinePsychomotor vigilance test (PVT)
fatigue (vigilance)baselineKarolinska Sleepiness Scale (KSS),
motor coordination (vigilance)baselinethe angle of the steering wheel

Secondary

MeasureTime frameDescription
sleepbaseline(EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),
temperaturebaselinemeasured each minute with e-tact medical device
heart ratebaseline

Countries

France

Contacts

STUDY_CHAIRAntoine Gauthier

UMR 1075 COMETE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026