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Effect of Countermeasures on Nocturnal Driving Performance

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01070004
Acronym
KILLSLEEP
Enrollment
72
Registered
2010-02-17
Start date
2010-01-31
Completion date
2011-08-31
Last updated
2012-06-14

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

Conditions

Sleepiness

Keywords

sleepiness, driving, countermeasures, coffee, blue light exposure, physical activity

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).

Interventions

OTHERReal driving situation

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.

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.

Sponsors

ERANET
CollaboratorUNKNOWN
INSERM ERI27 Mobilités Cognition et Temporalité
CollaboratorUNKNOWN
Hotel Dieu Hospital
CollaboratorOTHER
IMF, CNRS UMR-5231
CollaboratorUNKNOWN
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frame
Number of inappropriate line crossings identified from video recordingsFirst, second and third visit

Secondary

MeasureTime frame
sleep efficiency during the subsequent sleepafter each driving session
Standard deviation of the position of the car identified from the video recordingsFirst, second and third visit
Self-rated sleepiness during drivingFirst, second and third visit
Self-rated fatigue during drivingFirst, second and third visit
Time course of EEG slow wave activity during subsequent sleepFirst, second and third visit
Sleep latency during subsequent sleepafter each driving session
Caffeine sensitivityat first visit
Reaction time and percentage of errors at cognitive testsFirst visit
PER3, COMT, ADORA2A and ADA polymorphismbefore driving session
Habitual sleep patternsat first visit
Chronotypeat first visit
Saliva cortisol and amylase concentrationbefore and after the driving session and after sleep recuperation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026