Chronic Sleep Restriction and Driving (PRIVASOM)
| Tracking Information | |||||
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| First Received Date ICMJE | November 16, 2007 | ||||
| Last Updated Date | April 19, 2010 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Standard deviation from the centre of the road on driving simulator [ Time Frame: 1 week ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Standard deviation from the centre of the road on driving simulator [ Time Frame: 1 week ] | ||||
| Change History | Complete list of historical versions of study NCT00560456 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 [ Time Frame: 1 week ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 [ Time Frame: 1 week ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chronic Sleep Restriction and Driving | ||||
| Official Title ICMJE | Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors | ||||
| 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. |
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| 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:
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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Sleep Deprivation | ||||
| Intervention ICMJE | Other: Chronic sleep restriction and driving simulator
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy subjects inclusion criteria :
Snorers inclusion criteria :
Exclusion Criteria: Healthy subjects exclusion criteria :
Snorers exclusion criteria :
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| Gender | Male | ||||
| Ages | 20 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00560456 | ||||
| Other Study ID Numbers ICMJE | CHUBX 2006/09 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux | ||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||
| Collaborators ICMJE | PREDIT Go4 | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Bordeaux | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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