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Effect of Countermeasures on Nocturnal Driving Performance (KILLSLEEP)

Primary Purpose

Sleepiness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Real driving situation
Driving simulator
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleepiness focused on measuring sleepiness, driving, countermeasures, coffee, blue light exposure, physical activity

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU de Bordeaux Groupe Hospitalier Pellegrin
  • Université de Caen Basse Normandie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blue light

Physical activity

Arm Description

Exposure to 460-nm monochromatic light (blue light)

15 minutes of physical activity at a low intensity

Outcomes

Primary Outcome Measures

Number of inappropriate line crossings identified from video recordings

Secondary Outcome Measures

Standard deviation of the position of the car identified from the video recordings
Self-rated sleepiness during driving
Self-rated fatigue during driving
Sleep latency during subsequent sleep
sleep efficiency during the subsequent sleep
Time course of EEG slow wave activity during subsequent sleep
Saliva cortisol and amylase concentration
Caffeine sensitivity
Reaction time and percentage of errors at cognitive tests
PER3, COMT, ADORA2A and ADA polymorphism
Habitual sleep patterns
Chronotype

Full Information

First Posted
February 15, 2010
Last Updated
June 13, 2012
Sponsor
University Hospital, Bordeaux
Collaborators
ERANET, INSERM ERI27 Mobilités Cognition et Temporalité, Hotel Dieu Hospital, IMF, CNRS UMR-5231
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1. Study Identification

Unique Protocol Identification Number
NCT01070004
Brief Title
Effect of Countermeasures on Nocturnal Driving Performance
Acronym
KILLSLEEP
Official Title
Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
ERANET, INSERM ERI27 Mobilités Cognition et Temporalité, Hotel Dieu Hospital, IMF, CNRS UMR-5231

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleepiness
Keywords
sleepiness, driving, countermeasures, coffee, blue light exposure, physical activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blue light
Arm Type
Experimental
Arm Description
Exposure to 460-nm monochromatic light (blue light)
Arm Title
Physical activity
Arm Type
Experimental
Arm Description
15 minutes of physical activity at a low intensity
Intervention Type
Other
Intervention Name(s)
Real driving situation
Intervention Description
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
Intervention Name(s)
Driving simulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of inappropriate line crossings identified from video recordings
Time Frame
First, second and third visit
Secondary Outcome Measure Information:
Title
Standard deviation of the position of the car identified from the video recordings
Time Frame
First, second and third visit
Title
Self-rated sleepiness during driving
Time Frame
First, second and third visit
Title
Self-rated fatigue during driving
Time Frame
First, second and third visit
Title
Sleep latency during subsequent sleep
Time Frame
after each driving session
Title
sleep efficiency during the subsequent sleep
Time Frame
after each driving session
Title
Time course of EEG slow wave activity during subsequent sleep
Time Frame
First, second and third visit
Title
Saliva cortisol and amylase concentration
Time Frame
before and after the driving session and after sleep recuperation
Title
Caffeine sensitivity
Time Frame
at first visit
Title
Reaction time and percentage of errors at cognitive tests
Time Frame
First visit
Title
PER3, COMT, ADORA2A and ADA polymorphism
Time Frame
before driving session
Title
Habitual sleep patterns
Time Frame
at first visit
Title
Chronotype
Time Frame
at first visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Philip, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pierre Denise, Pr
Organizational Affiliation
INSERM ERI27
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Université de Caen Basse Normandie
City
Caen
ZIP/Postal Code
14032
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23094031
Citation
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.
Results Reference
derived

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Effect of Countermeasures on Nocturnal Driving Performance

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