Chronic Sleep Restriction and Driving (PRIVASOM)

University Hospital of Bordeaux

Status: Completed

Conditions: Sleep Deprivation

Treatments: Other: Chronic sleep restriction and driving simulator

Study type: Interventional

Funder types: Other

Identifiers

NCT00560456

CHUBX 2006/09

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

1

Experimental group

Description:

snorers

Treatment:

Other: Chronic sleep restriction and driving simulator

2

Other group

Description:

healthy volonters (control)

Treatment:

Other: Chronic sleep restriction and driving simulator

3

Experimental group

Description:

young subjects

Treatment:

Other: Chronic sleep restriction and driving simulator

4

Experimental group

Description:

mature subjects

Treatment:

Other: Chronic sleep restriction and driving simulator