Chronic Sleep Restriction and Driving (PRIVASOM)

This study has been completed.
Sponsor:
Collaborator:
PREDIT Go4
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00560456
First received: November 16, 2007
Last updated: April 19, 2010
Last verified: April 2010

November 16, 2007
April 19, 2010
November 2007
October 2009   (final data collection date for primary outcome measure)
Standard deviation from the centre of the road on driving simulator [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Standard deviation from the centre of the road on driving simulator [ Time Frame: 1 week ]
Complete list of historical versions of study NCT00560456 on ClinicalTrials.gov Archive Site
Number of inappropriate line crossing on driving simulator Number of lapses assessed by SRTT 10 % of slowest reaction time Mean sleep latency at 6*20-minutes multi sleep latency test. Subjective sleepiness (Karolinska and VAS) Nocturnal PSG [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Number of inappropriate line crossing on driving simulator Number of lapses assessed by SRTT 10 % of slowest reaction time Mean sleep latency at 6*20-minutes multi sleep latency test. Subjective sleepiness (Karolinska and VAS) Nocturnal PSG [ Time Frame: 1 week ]
Not Provided
Not Provided
 
Chronic Sleep Restriction and Driving
Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors

Young subjects and patients with nocturnal respiratory disorders are frequently involved in sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or snorers on simulated driving, objective and subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.

Principal objective :

To determine whether chronic sleep restriction affects more snorers driving performances than healthy subjects' driving performances.

To determine whether chronic sleep restriction affects more young people driving performances than mature subjects' driving performances.

Secondary objective :

To determine whether chronic sleep restriction affects more snorers reaction time performance and sleepiness than non snorers subjects'.

To determine whether chronic sleep restriction affects more young people reaction time performance and sleepiness than mature subjects'.

To determine how age and snoring intensity affects the degradation of performance over the 5 days of sleep deprivation.

To determine age-related changes in the time course of sleepiness during 5 days of chronic sleep restriction.

To compare the impact of total sleep or chronic sleep restriction on driving performances according to the age and snoring intensity.

To determine recovery facilities to chronic sleep restriction according to the age and snoring intensity.

Study plan :

G2: Group of subjects:

  • patients
  • controls

B1: Baseline normal night:

One night of normal sleep

A2: Acute sleep deprivation:

Night 1: night of total sleep deprivation Night 2: night of sleep recovery

C6: Chronic sleep deprivation:

Night 1 to 5: nights of sleep restriction Night 6: night of sleep recovery

Experimental plan : S20 <G2> *B1 * A2 *C6

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Sleep Deprivation
Other: Chronic sleep restriction and driving simulator
  • One night of normal sleep
  • Driving simulator
  • Night 1: night of total sleep deprivation
  • Night 2: night of sleep recovery
  • Night 1 to 5: nights of sleep restriction
  • Driving simulator after night 1 to 5
  • Night 6: night of sleep recovery
  • Driving simulator
  • Experimental: 1
    snorers
    Intervention: Other: Chronic sleep restriction and driving simulator
  • 2
    healthy volonters (control)
    Intervention: Other: Chronic sleep restriction and driving simulator
  • Experimental: 3
    young subjects
    Intervention: Other: Chronic sleep restriction and driving simulator
  • Experimental: 4
    mature subjects
    Intervention: Other: Chronic sleep restriction and driving simulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy subjects inclusion criteria :

  • Healthy males without snoring nor subjective daytime sleepiness (Epworth <9)
  • Intermediate chronotype
  • Hypopnea/apnea index <5
  • Periodic movement index <5
  • Sleep efficiency > 85 %
  • Not taking medication modifying alertness
  • Mean driving distance per year 15000 km
  • Regular sleep-wake schedule.

Snorers inclusion criteria :

  • Snoring males without subjective daytime sleepiness (Epworth <9)
  • Intermediate chronotype
  • Hypopnea/apnea index <5
  • Periodic movement index < 5
  • Sleep efficiency > 85 %
  • Not taking medication modifying alertness
  • Mean driving distance per year 15000 km
  • Regular sleep-wake schedule

Exclusion Criteria:

Healthy subjects exclusion criteria :

  • Short or long sleeper
  • Shift- or night-worker
  • Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders
  • Alcohol
  • Consumption of illicit drugs.

Snorers exclusion criteria :

  • Short or long sleeper
  • Shift- or night-worker
  • Mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders,
  • Sleep disorder except snoring
  • Alcohol
  • Consumption of illicit drugs.
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00560456
CHUBX 2006/09
No
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
University Hospital, Bordeaux
PREDIT Go4
Principal Investigator: Pierre Philip, MD University Hospital Bordeaux, France
University Hospital, Bordeaux
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP