Ignite Creation Date:
2024-05-05 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00560456
Status:
COMPLETED
Last Update Posted:
2010-04-20
First Post:
2007-11-16
Brief Title:
Chronic Sleep Restriction and Driving
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers Interindividual Vulnerability and Recovery Factors
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIVASOM
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None