Chronic Sleep Restriction and Driving (PRIVASOM)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Deprivation |
Other: Chronic sleep restriction and driving simulator |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors |
- Standard deviation from the centre of the road on driving simulator [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
snorers
|
Other: Chronic sleep restriction and driving simulator
|
|
2
healthy volonters (control)
|
Other: Chronic sleep restriction and driving simulator
|
|
Experimental: 3
young subjects
|
Other: Chronic sleep restriction and driving simulator
|
|
Experimental: 4
mature subjects
|
Other: Chronic sleep restriction and driving simulator
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| France | |
| University Hospital Bordeaux, Groupe Hospitalier Pellegrin | |
| Bordeaux cedex, France, 33076 | |
| Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC) | |
| Strasbourg, France, 67000 | |
| Principal Investigator: | Pierre Philip, MD | University Hospital Bordeaux, France |
More Information
No publications provided
| Responsible Party: | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00560456 History of Changes |
| Other Study ID Numbers: | CHUBX 2006/09 |
| Study First Received: | November 16, 2007 |
| Last Updated: | April 19, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Bordeaux:
|
Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness |
Additional relevant MeSH terms:
|
Sleep Deprivation Dyssomnias Sleep Disorders Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013