Effect of Countermeasures on Nocturnal Driving Performance (KILLSLEEP)

This study has been completed.
Sponsor:
Collaborators:
ERANET
INSERM ERI27 Mobilités Cognition et Temporalité
Centre du Sommeil et de la Vigilance - Hôpital Hôtel – Dieu
IMF, CNRS UMR-5231
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01070004
First received: February 15, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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 Intervention
Sleepiness
Other: Real driving situation
Other: Driving simulator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Number of inappropriate line crossings identified from video recordings [ Time Frame: First, second and third visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standard deviation of the position of the car identified from the video recordings [ Time Frame: First, second and third visit ] [ Designated as safety issue: No ]
  • Self-rated sleepiness during driving [ Time Frame: First, second and third visit ] [ Designated as safety issue: No ]
  • Self-rated fatigue during driving [ Time Frame: First, second and third visit ] [ Designated as safety issue: No ]
  • Sleep latency during subsequent sleep [ Time Frame: after each driving session ] [ Designated as safety issue: No ]
  • sleep efficiency during the subsequent sleep [ Time Frame: after each driving session ] [ Designated as safety issue: No ]
  • Time course of EEG slow wave activity during subsequent sleep [ Time Frame: First, second and third visit ] [ Designated as safety issue: No ]
  • Saliva cortisol and amylase concentration [ Time Frame: before and after the driving session and after sleep recuperation ] [ Designated as safety issue: No ]
  • Caffeine sensitivity [ Time Frame: at first visit ] [ Designated as safety issue: No ]
  • Reaction time and percentage of errors at cognitive tests [ Time Frame: First visit ] [ Designated as safety issue: No ]
  • PER3, COMT, ADORA2A and ADA polymorphism [ Time Frame: before driving session ] [ Designated as safety issue: No ]
  • Habitual sleep patterns [ Time Frame: at first visit ] [ Designated as safety issue: No ]
  • Chronotype [ Time Frame: at first visit ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070004

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
Centre du Sommeil et de la Vigilance - Hôpital Hôtel – Dieu
IMF, CNRS UMR-5231
Investigators
Study Director: Pierre Philip, Pr University Hospital, Bordeaux
Principal Investigator: Pierre Denise, Pr INSERM ERI27
  More Information

No publications provided by University Hospital, Bordeaux

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01070004     History of Changes
Other Study ID Numbers: CHUBX 2009/14
Study First Received: February 15, 2010
Last Updated: June 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
sleepiness
driving
countermeasures
coffee
blue light exposure
physical activity

ClinicalTrials.gov processed this record on April 20, 2014