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SleepinessKILLSLEEPNCT01070004

Effect of Countermeasures on Nocturnal Driving Performance

A study testing Real driving situation and Driving simulator in people with Sleepiness, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sleepiness
What is being tested?
Real driving situation and Driving simulator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesFrance
Study dates
Jan 2010to Aug 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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),
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  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Bordeaux Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • Université de Caen Basse Normandie

    Caen, 14032

Other trials in France

About this study

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

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
Being tested
Real driving situation, Driving simulator
Keywords
sleepiness, driving, countermeasures, coffee, blue light exposure, physical activity
Medical subject headings
Sleepiness, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real driving situationOther

    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 simulatorOther

    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.

Study groups in NCT01070004
Study groupRoleWhat they receive
Blue lightExperimentalExposure to 460-nm monochromatic light (blue light)
Receives: Other: Real driving situation
Physical activityExperimental15 minutes of physical activity at a low intensity
Receives: Other: Driving simulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of inappropriate line crossings identified from video recordings

    Measured: First, second and third visit

Secondary outcomes (12)

  1. Standard deviation of the position of the car identified from the video recordings

    Measured: First, second and third visit

  2. Self-rated sleepiness during driving

    Measured: First, second and third visit

  3. Self-rated fatigue during driving

    Measured: First, second and third visit

  4. Sleep latency during subsequent sleep

    Measured: after each driving session

  5. sleep efficiency during the subsequent sleep

    Measured: after each driving session

  6. Time course of EEG slow wave activity during subsequent sleep

    Measured: First, second and third visit

  7. Saliva cortisol and amylase concentration

    Measured: before and after the driving session and after sleep recuperation

  8. Caffeine sensitivity

    Measured: at first visit

  9. Reaction time and percentage of errors at cognitive tests

    Measured: First visit

  10. PER3, COMT, ADORA2A and ADA polymorphism

    Measured: before driving session

  11. Habitual sleep patterns

    Measured: at first visit

  12. Chronotype

    Measured: at first visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01070004
Sponsor's protocol ID
CHUBX 2009/14
Acronym
KILLSLEEP
Status last verified
Jun 2012
First submitted
15 Feb 2010
Last updated
14 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23094031

Questions about this trial

What is this clinical trial studying?

A study testing Real driving situation and Driving simulator in people with Sleepiness, run by University Hospital, Bordeaux at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of inappropriate line crossings identified from video recordings (time frame: First, second and third visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01070004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.

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