CClinicalTrials.gg
CompletedNCT00560456PRIVASOMUpdated Jun 1, 2026

Chronic Sleep Restriction and Driving

An interventional study of Chronic sleep restriction and driving simulator in Sleep Deprivation, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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

02

Conditions studied

  • Sleep Deprivation

Keywords

  • Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
03

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    1

    snorers

    Other: Chronic sleep restriction and driving simulator

  • Other
    2

    healthy volonters (control)

    Other: Chronic sleep restriction and driving simulator

  • Experimental
    3

    young subjects

    Other: Chronic sleep restriction and driving simulator

  • Experimental
    4

    mature subjects

    Other: Chronic sleep restriction and driving simulator

Interventions

  • OtherChronic 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

05

What researchers measure

Primary outcomes

  1. Standard deviation from the centre of the road on driving simulator

    Time frame: 1 week

Secondary outcomes

  1. 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

06

Study locations

2 sites
  • University Hospital Bordeaux, Groupe Hospitalier Pellegrin
    Bordeaux, 33076, France
  • Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
    Strasbourg, 67000, France
07

Registry details

Key details

Study ID
NCT00560456
Lead sponsor
University Hospital, Bordeaux
Collaborators
PREDIT Go4
Responsible party
Sponsor
First posted
Nov 19, 2007
Start date
Nov 2007
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Jun 1, 2026

Study contacts

Pierre Philip, MD
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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