Clinical trial NCT01070004: Effect of Countermeasures on Nocturnal Driving Performance
Official title: Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleepiness
Keywords: sleepiness
driving
countermeasures
coffee
blue light exposure
physical activity
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: ERANET
name: INSERM ERI27 Mobilités Cognition et Temporalité
name: Hotel Dieu Hospital
name: IMF, CNRS UMR-5231
First posted: 2010-02-17
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of inappropriate line crossings identified from video recordings
timeFrame: First, second and third visit
Secondary outcomes:
measure: Standard deviation of the position of the car identified from the video recordings
timeFrame: First, second and third visit
measure: Self-rated sleepiness during driving
timeFrame: First, second and third visit
measure: Self-rated fatigue during driving
timeFrame: First, second and third visit
measure: Sleep latency during subsequent sleep
timeFrame: after each driving session
measure: sleep efficiency during the subsequent sleep
timeFrame: after each driving session
measure: Time course of EEG slow wave activity during subsequent sleep
timeFrame: First, second and third visit
measure: Saliva cortisol and amylase concentration
timeFrame: before and after the driving session and after sleep recuperation
measure: Caffeine sensitivity
timeFrame: at first visit
measure: Reaction time and percentage of errors at cognitive tests
timeFrame: First visit
measure: PER3, COMT, ADORA2A and ADA polymorphism
timeFrame: before driving session
measure: Habitual sleep patterns
timeFrame: at first visit
measure: Chronotype
timeFrame: at first visit
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux Groupe Hospitalier Pellegrin
city: Caen
country: France
facility: Université de Caen Basse Normandie
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre Philip, Pr
role: STUDY_DIRECTOR
affiliation: INSERM ERI27
name: Pierre Denise, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taillard J, Capelli A, Sagaspe P, Anund A, Akerstedt T, Philip P. In-car nocturnal blue light exposure improves motorway driving: a randomized controlled trial. PLoS One. 2012;7(10):e46750. doi: 10.1371/journal.pone.0046750. Epub 2012 Oct 19.