Chronic Sleep Restriction and Driving (PRIVASOM)
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chronic sleep restriction and driving simulator
Sponsored by
About this trial
This is an interventional health services research trial for Sleep Deprivation focused on measuring Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
Eligibility Criteria
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.
Sites / Locations
- University Hospital Bordeaux, Groupe Hospitalier Pellegrin
- Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
snorers
healthy volonters (control)
young subjects
mature subjects
Outcomes
Primary Outcome Measures
Standard deviation from the centre of the road on driving simulator
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00560456
First Posted
November 16, 2007
Last Updated
April 19, 2010
Sponsor
University Hospital, Bordeaux
Collaborators
PREDIT Go4
1. Study Identification
Unique Protocol Identification Number
NCT00560456
Brief Title
Chronic Sleep Restriction and Driving
Acronym
PRIVASOM
Official Title
Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
PREDIT Go4
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
snorers
Arm Title
2
Arm Type
Other
Arm Description
healthy volonters (control)
Arm Title
3
Arm Type
Experimental
Arm Description
young subjects
Arm Title
4
Arm Type
Experimental
Arm Description
mature subjects
Intervention Type
Other
Intervention Name(s)
Chronic sleep restriction and driving simulator
Intervention Description
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
Primary Outcome Measure Information:
Title
Standard deviation from the centre of the road on driving simulator
Time Frame
1 week
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Philip, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
City
Bordeaux cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
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Chronic Sleep Restriction and Driving
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