Effect of Countermeasures on Nocturnal Driving Performance

NCT ID: NCT01070004

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-08-31

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).

Conditions

Sleepiness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Blue light

Exposure to 460-nm monochromatic light (blue light)

Group Type: EXPERIMENTAL

Real driving situation

Intervention Type: OTHER

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.

Physical activity

15 minutes of physical activity at a low intensity

Group Type: EXPERIMENTAL

Driving simulator

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

ERANET

UNKNOWN

Sponsor Role: collaborator

INSERM ERI27 Mobilités Cognition et Temporalité

UNKNOWN

Sponsor Role: collaborator

Hotel Dieu Hospital

OTHER

Sponsor Role: collaborator

IMF, CNRS UMR-5231

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Philip, Pr

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Pierre Denise, Pr

Role: PRINCIPAL_INVESTIGATOR

INSERM ERI27

Locations

CHU de Bordeaux Groupe Hospitalier Pellegrin

Bordeaux, , France

Université de Caen Basse Normandie

Caen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23094031 (View on PubMed)

Other Identifiers

CHUBX 2009/14

Identifier Type: -

Identifier Source: org_study_id