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Effect of Countermeasures on Nocturnal Driving Performance (KILLSLEEP)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Sleepiness

Treatments

Other: Driving simulator
Other: Real driving situation

Study type

Interventional

Funder types

Other

Identifiers

NCT01070004
CHUBX 2009/14

Details and patient eligibility

About

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).

Enrollment

72 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Blue light
Experimental group
Description:
Exposure to 460-nm monochromatic light (blue light)
Treatment:
Other: Real driving situation
Physical activity
Experimental group
Description:
15 minutes of physical activity at a low intensity
Treatment:
Other: Driving simulator

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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