Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2007-11-30
2009-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1
snorers
Chronic 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
2
healthy volonters (control)
Chronic 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
3
young subjects
Chronic 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
4
mature subjects
Chronic 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
Interventions
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Chronic 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
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* Shift- or night-worker
* Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders
* Alcohol
* Consumption of illicit drugs.
* Short or long sleeper
* Shift- or night-worker
* Mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders,
* Sleep disorder except snoring
* Alcohol
* Consumption of illicit drugs.
20 Years
55 Years
MALE
Yes
Sponsors
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PREDIT Go4
UNKNOWN
University Hospital, Bordeaux
OTHER
Responsible Party
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University Hospital, Bordeaux
Principal Investigators
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Pierre Philip, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, , France
Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
Strasbourg, , France
Countries
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Other Identifiers
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CHUBX 2006/09
Identifier Type: -
Identifier Source: org_study_id
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