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Chronic Sleep Restriction and Driving

Not Applicable
Completed
Conditions
Sleep Deprivation
Interventions
Other: Chronic sleep restriction and driving simulator
Registration Number
NCT00560456
Lead Sponsor
University Hospital, Bordeaux
Brief Summary

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.

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Chronic sleep restriction and driving simulatorsnorers
2Chronic sleep restriction and driving simulatorhealthy volonters (control)
4Chronic sleep restriction and driving simulatormature subjects
3Chronic sleep restriction and driving simulatoryoung subjects
Primary Outcome Measures
NameTimeMethod
Standard deviation from the centre of the road on driving simulator1 week
Secondary Outcome Measures
NameTimeMethod
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 PSG1 week

Trial Locations

Locations (2)

University Hospital Bordeaux, Groupe Hospitalier Pellegrin

🇫🇷

Bordeaux cedex, France

Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)

🇫🇷

Strasbourg, France

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