Chronic Sleep Restriction and Driving (PRIVASOM)

This study has been completed.
Sponsor:
Collaborator:
PREDIT Go4
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00560456
First received: November 16, 2007
Last updated: April 19, 2010
Last verified: April 2010
  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

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: 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
  • 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
Experimental: 3
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
Experimental: 4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux cedex, France, 33076
Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Bordeaux
PREDIT Go4
Investigators
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 July 28, 2014