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Completed

NCT Number: NCT03978026

Vigilance and Simulated Driving After a Nap

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PFRS

Caen, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nap

Behavioral

Each participant is compared to himself in 4 conditions,

Primary outcomes

  1. driving performances

    Time frame: baseline

    number of lateral deviations of the vehicule

  2. sleepiness (vigilance)

    Time frame: baseline

    Psychomotor vigilance test (PVT)

  3. fatigue (vigilance)

    Time frame: baseline

    Karolinska Sleepiness Scale (KSS),

  4. motor coordination (vigilance)

    Time frame: baseline

    the angle of the steering wheel

Secondary outcomes

  1. sleep

    Time frame: baseline

    (EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),

  2. temperature

    Time frame: baseline

    measured each minute with e-tact medical device

  3. heart rate

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Acronym: SOMBOX

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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