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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-A00648-43 | Other Identifier | ansm |
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| Name | Class |
|---|---|
| PREDIT Go4 | UNKNOWN |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | snorers |
|
| 2 | Other | healthy volonters (control) |
|
| 3 | Experimental | young subjects |
|
| 4 | Experimental | mature subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronic sleep restriction and driving simulator | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard deviation from the centre of the road on driving simulator | 1 week |
| 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 |
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Inclusion Criteria:
Healthy subjects inclusion criteria :
Snorers inclusion criteria :
Exclusion Criteria:
Healthy subjects exclusion criteria :
Snorers exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Philip, MD | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bordeaux, Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France | |||
| Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC) |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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|
| Strasbourg |
| 67000 |
| France |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |