Skip to main content
OpenTrials
Completed

NCT Number: NCT01070004

Effect of Countermeasures on Nocturnal Driving Performance

Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because of conflicts between physiological needs and social or professional activities, it is necessary to develop affordable countermeasure to sleepiness. In real-life driving studies, nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect of caffeine is quick but brief and varies between individuals. There is a need for more knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic light (blue light) decreases subjective sleepiness and improves performances. One objective of this project is to investigate whether blue light exposure during driving would be useful in a real driving situation when sleepiness becomes acute. Owing to the fact that our knowledge of the effects of exercise on driving is very sparse and to the absolutely need to standardize the bouts of exercise that will be applied to the subjects. One objective of the present study will be to investigate in a simulator study the effects of a bout of moderate exercise on participants driving ability when sleepiness becomes acute. Nocturnal neurobehavioral performance varies widely between individuals and only certain subjects seem significantly affected by sleep loss. It is of interest to find biological markers for sleep drive to identify vulnerable drivers to sleep deprivation or to identify responders to sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to determine individual differences (genetic, hormonal and cognitive) in the impairment of driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and coffee).

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux Groupe Hospitalier Pellegrin, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20-25-year-old healthy Volunteers or of 40-50 years, male, Caucasian,
  • Presenting no disorder of the perception,
  • Taking no treatment interfering with the sleep, the attentiveness and the circadian system,
  • BMI ≥18 et ≤ 27
  • Moderate Drinker of coffee(café) (2-3 cups a day) •
  • Presenting no medical history or evolutionary pathology,
  • Not presenting syndrome of apneas / hypopnea during the sleep (IAH < 5 for 20-25 years and 10 for 40-50 years),
  • Not presenting syndrome of periodic movements during the sleep (Index of MPS < 15),
  • Not professional Driver, having their driving license for at least 3 years or 2 years for the drivers who followed the learning anticipated and driving between 10000 and 20000 km a year,
  • Having looked in writing their consent to participate in the study,
  • Having regular schedules of life 3 days before going into the study,
  • Registers on the Social Security and on the register of the healthy volunteers.

Exclusion criteria

  • Night workers,
  • Any evolutionary psychiatric affections (psychosis, disorder(confusion) of the mood or the anxiety),
  • All the sleeping disorders (sleep apneas, periodic leg movements, narcolepsy, phase delay, advance of phase),
  • Any evolutionary neurological affections (brain tumour, epilepsy, Headache, brain vascular accident, calcifies, myoclonia , chorea, neuropathy, muscular dystrophies, myotonic dystrophy),
  • Cardiovascular Pathologies (arterial high blood pressure, cardiac insufficiency, coronary disease, vascular disorders(confusions)),
  • Lung Pathologies (BPCO, BPR),
  • Renal Disorders(Confusions) (renal insufficiency, nephrolithiases),
  • Endocrine Pathologies (dysthyroid, diabetes),
  • Drug addiction, alcoholic dependence during the last 6 months,
  • Having made a trans-meridian journey (± 3 hours) in last 3 months.

Treatment and study plan

Real driving situation

Other

Continuous blue light exposure during driving compared to effects of coffee (2*200 mg of caffeine) and coffee placebo on 4h night-time real driving situation. Inside this arm, each volunteer will be randomly allocated and will all receive : continuous blue light exposure, coffee and coffee placebo at each driving session with at least 1 week between each condition.

Driving simulator

Other

15 minutes of physical activity at a low intensity before driving compared to effects of coffee (2*200 mg of caffeine) and coffee placebo on 4h night-time driving simulator. Inside this arm, each volunteer will be randomly allocated and will all receive : 15 minutes of physical activity, coffee and coffee placebo at each driving session with at least 1 week between each condition.

Primary outcomes

  1. Number of inappropriate line crossings identified from video recordings

    Time frame: First, second and third visit

Secondary outcomes

  1. Standard deviation of the position of the car identified from the video recordings

    Time frame: First, second and third visit

  2. Self-rated sleepiness during driving

    Time frame: First, second and third visit

  3. Self-rated fatigue during driving

    Time frame: First, second and third visit

  4. Sleep latency during subsequent sleep

    Time frame: after each driving session

  5. sleep efficiency during the subsequent sleep

    Time frame: after each driving session

  6. Time course of EEG slow wave activity during subsequent sleep

    Time frame: First, second and third visit

  7. Saliva cortisol and amylase concentration

    Time frame: before and after the driving session and after sleep recuperation

  8. Caffeine sensitivity

    Time frame: at first visit

  9. Reaction time and percentage of errors at cognitive tests

    Time frame: First visit

  10. PER3, COMT, ADORA2A and ADA polymorphism

    Time frame: before driving session

  11. Habitual sleep patterns

    Time frame: at first visit

  12. Chronotype

    Time frame: at first visit

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • ERANET
  • Hotel Dieu Hospital
  • IMF, CNRS UMR-5231
  • INSERM ERI27 Mobilités Cognition et Temporalité

Registry information

Official study title

Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)

Acronym: KILLSLEEP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Jun 14, 2012

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.

Published trials that share one or more normalized conditions with this study.