Effect of Countermeasures on Nocturnal Driving Performance

Sleepiness Clinical Trial

— KILLSLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070004
• Other study ID #: CHUBX 2009/14
• Status: Completed
• Phase: N/A
• First received: February 15, 2010
• Last updated: June 13, 2012
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleepiness

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Bordeaux Groupe Hospitalier Pellegrin	Bordeaux
France	Université de Caen Basse Normandie	Caen

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	ERANET, Hotel Dieu Hospital, IMF, CNRS UMR-5231, INSERM ERI27 Mobilités Cognition et Temporalité

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inappropriate line crossings identified from video recordings		First, second and third visit	No
Secondary	Standard deviation of the position of the car identified from the video recordings		First, second and third visit	No
Secondary	Self-rated sleepiness during driving		First, second and third visit	No
Secondary	Self-rated fatigue during driving		First, second and third visit	No
Secondary	Sleep latency during subsequent sleep		after each driving session	No
Secondary	sleep efficiency during the subsequent sleep		after each driving session	No
Secondary	Time course of EEG slow wave activity during subsequent sleep		First, second and third visit	No
Secondary	Saliva cortisol and amylase concentration		before and after the driving session and after sleep recuperation	No
Secondary	Caffeine sensitivity		at first visit	No
Secondary	Reaction time and percentage of errors at cognitive tests		First visit	No
Secondary	PER3, COMT, ADORA2A and ADA polymorphism		before driving session	No
Secondary	Habitual sleep patterns		at first visit	No
Secondary	Chronotype		at first visit	No