Chronic Sleep Restriction and Driving

Study Overview
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Brief Summary
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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
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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

Official Title
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Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Other: Chronic sleep restriction and driving simulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>snorers | Other: Chronic sleep restriction and driving simulator<br>* 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<br>|
| Other: 2<br>healthy volonters (control) | Other: Chronic sleep restriction and driving simulator<br>* 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<br>|
| Experimental: 3<br>young subjects | Other: Chronic sleep restriction and driving simulator<br>* 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<br>|
| Experimental: 4<br>mature subjects | Other: Chronic sleep restriction and driving simulator<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation from the centre of the road on driving simulator |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness