Effect of Countermeasures on Nocturnal Driving Performance (KILLSLEEP)

• ClinicalTrials.gov Identifier: NCT01070004
• Recruitment Status: Completed
• First Posted: February 17, 2010
• Last Update Posted: June 14, 2012
• Sponsor: University Hospital, Bordeaux
• Collaborators: ERANET; INSERM ERI27 Mobilités Cognition et Temporalité; Hotel Dieu Hospital; IMF, CNRS UMR-5231
• Information provided by (Responsible Party): University Hospital, Bordeaux

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Sleepiness	Other: Real driving situation; Other: Driving simulator	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)
• Study Start Date: January 2010
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of inappropriate line crossings identified from video recordings [ Time Frame: First, second and third visit ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

France

CHU de Bordeaux Groupe Hospitalier Pellegrin

Bordeaux, France, 33076

Université de Caen Basse Normandie

Caen, France, 14032

Sponsors and Collaborators

University Hospital, Bordeaux

ERANET

INSERM ERI27 Mobilités Cognition et Temporalité

Hotel Dieu Hospital

IMF, CNRS UMR-5231

Investigators

• Study Director: Pierre Philip, Pr; University Hospital, Bordeaux
• Principal Investigator: Pierre Denise, Pr; INSERM ERI27

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT01070004
• Other Study ID Numbers: CHUBX 2009/14
• First Posted: February 17, 2010
• Last Update Posted: June 14, 2012
• Last Verified: June 2012

Keywords provided by University Hospital, Bordeaux:

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

Additional relevant MeSH terms:

Sleepiness