Chronic Sleep Restriction and Driving (PRIVASOM)

May 28, 2026 updated by: University Hospital, Bordeaux

Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • University Hospital Bordeaux, Groupe Hospitalier Pellegrin
      • Strasbourg, France, 67000
        • Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Standard deviation from the centre of the road on driving simulator
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

PREDIT Go4

Investigators

  • Principal Investigator: Pierre Philip, MD, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimated)

November 19, 2007

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2006/09
  • 2006-A00648-43 (Other Identifier: ansm)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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