Chronic Sleep Restriction and Driving - Full Text View

Sponsors and Collaborators:	University Hospital, Bordeaux PREDIT Go4
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00560456

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Standard deviation from the centre of the road on driving simulator [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental snorers	Other: Chronic sleep restriction and driving simulator 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
2 healthy volonters (control)	Other: Chronic sleep restriction and driving simulator 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
3: Experimental young subjects	Other: Chronic sleep restriction and driving simulator 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
4: Experimental mature subjects	Other: Chronic sleep restriction and driving simulator 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

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560456

Locations

France
University Hospital Bordeaux, Groupe Hospitalier Pellegrin	Recruiting
Bordeaux cedex, France, 33076
Contact: Pierre PHILIP, MD 05 57 65 60 58 pr.philip@free.fr
Principal Investigator: Pierre Philip, MD
Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)	Recruiting
Strasbourg, France, 67000
Contact: Daniel GRUCKERT, MD 03 90 24 40 38 grucker@ipb.u-strasbg.fr
Principal Investigator: Daniel Gruckert, MD

Sponsors and Collaborators

University Hospital, Bordeaux

PREDIT Go4

Investigators

Principal Investigator:

Pierre Philip, MD

University Hospital Bordeaux, France

More Information

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX 2006/09
Study First Received:	November 16, 2007
Last Updated:	September 1, 2008
ClinicalTrials.gov Identifier:	NCT00560456
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

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Snoring
Neurologic Manifestations

Sleep Disorders
Dyssomnias
Healthy
Sleep Deprivation

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009