Chronic Sleep Restriction and Driving

NCT ID: NCT00560456

Last Updated: 2010-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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

Conditions

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Sleep Deprivation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

snorers

Group Type EXPERIMENTAL

Chronic sleep restriction and driving simulator

Intervention Type OTHER

* 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)

Group Type OTHER

Chronic sleep restriction and driving simulator

Intervention Type OTHER

* 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

young subjects

Group Type EXPERIMENTAL

Chronic sleep restriction and driving simulator

Intervention Type OTHER

* 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

mature subjects

Group Type EXPERIMENTAL

Chronic sleep restriction and driving simulator

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.


* 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

* Short or long sleeper
* Shift- or night-worker
* Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders
* Alcohol
* Consumption of illicit drugs.


* Short or long sleeper
* Shift- or night-worker
* Mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders,
* Sleep disorder except snoring
* Alcohol
* Consumption of illicit drugs.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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PREDIT Go4

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Bordeaux

Principal Investigators

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Pierre Philip, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

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University Hospital Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2006/09

Identifier Type: -

Identifier Source: org_study_id

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