Effect of Countermeasures on Nocturnal Driving Performance (KILLSLEEP)

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

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).

Study Overview

• Status: Completed
• Conditions: Sleepiness
• Intervention / Treatment: Other: Real driving situation; Other: Driving simulator

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux Groupe Hospitalier Pellegrin
  • Caen, France, 14032
    • Université de Caen Basse Normandie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue light; Exposure to 460-nm monochromatic light (blue light)	Other: Real 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.
Experimental: Physical activity; 15 minutes of physical activity at a low intensity	Other: Driving simulator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of inappropriate line crossings identified from video recordings	First, second and third visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Standard deviation of the position of the car identified from the video recordings	First, second and third visit
Self-rated sleepiness during driving	First, second and third visit
Self-rated fatigue during driving	First, second and third visit
Sleep latency during subsequent sleep	after each driving session
sleep efficiency during the subsequent sleep	after each driving session
Time course of EEG slow wave activity during subsequent sleep	First, second and third visit
Saliva cortisol and amylase concentration	before and after the driving session and after sleep recuperation
Caffeine sensitivity	at first visit
Reaction time and percentage of errors at cognitive tests	First visit
PER3, COMT, ADORA2A and ADA polymorphism	before driving session
Habitual sleep patterns	at first visit
Chronotype	at first visit

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Hotel Dieu Hospital; ERANET; INSERM ERI27 Mobilités Cognition et Temporalité; IMF, CNRS UMR-5231
• Investigators: Study Director: Pierre Philip, Pr, University Hospital, Bordeaux; Principal Investigator: Pierre Denise, Pr, INSERM ERI27

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: physical activity; coffee; driving; sleepiness; countermeasures; blue light exposure
• Additional Relevant MeSH Terms: Sleepiness
• Other Study ID Numbers: CHUBX 2009/14