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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00560456 |
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Date of registration:
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16/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chronic Sleep Restriction and Driving
PRIVASOM |
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Scientific title:
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Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00560456 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre Philip, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux, France |
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Key inclusion & exclusion 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.
Age minimum:
20 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Sleep Deprivation
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Intervention(s)
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Other: Chronic sleep restriction and driving simulator
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Primary Outcome(s)
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Standard deviation from the centre of the road on driving simulator
[Time Frame: 1 week]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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CHUBX 2006/09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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