Clinical trial NCT00560456: Chronic Sleep Restriction and Driving
Official title: Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: PREDIT Go4
First posted: 2007-11-19
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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.

Primary outcomes:
measure: Standard deviation from the centre of the road on driving simulator
timeFrame: 1 week
Secondary outcomes:
measure: 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
timeFrame: 1 week
Other outcomes:
Locations:
city: Bordeaux cedex
country: France
facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin
city: Strasbourg
country: France
facility: Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
Study officials:
affiliation: University Hospital Bordeaux, France
name: Pierre Philip, MD
role: PRINCIPAL_INVESTIGATOR
References: