Sleep DeprivationPRIVASOMNCT00560456
Chronic Sleep Restriction and Driving
A study testing Chronic sleep restriction and driving simulator in people with Sleep Deprivation, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Chronic sleep restriction and driving simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2007to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 %
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- 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
Who cannot join
- Healthy subjects exclusion criteria :
- Short or long sleeper
- Shift- or night-worker
- Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders
- Alcohol
- Consumption of illicit drugs.
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, 33076
Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)
Strasbourg, 67000
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Deprivation
- Being tested
- Chronic sleep restriction and driving simulator
- Keywords
- Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
- Medical subject headings
- Sleep Deprivation, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic sleep restriction and driving simulatorOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | snorers Receives: Other: Chronic sleep restriction and driving simulator |
| 2 | Other | healthy volonters (control) Receives: Other: Chronic sleep restriction and driving simulator |
| 3 | Experimental | young subjects Receives: Other: Chronic sleep restriction and driving simulator |
| 4 | Experimental | mature subjects Receives: Other: Chronic sleep restriction and driving simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation from the centre of the road on driving simulator
Measured: 1 week
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- PREDIT Go4
- Responsible party
- Sponsor
- Investigators
- Pierre Philip, MD, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560456
- Sponsor's protocol ID
- CHUBX 2006/09
- Other IDs
- 2006-A00648-43
- Acronym
- PRIVASOM
- Status last verified
- Apr 2010
- First submitted
- 16 Nov 2007
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors
- ClinicalTrials.gov ID
- NCT00560456
- Acronym / sponsor ID
- PRIVASOM / CHUBX 2006/09
- Conditions
- Sleep Deprivation
- Keywords
- Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- PREDIT Go4
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Chronic sleep restriction and driving simulatorsnorers |
| 2 | Other | Other: Chronic sleep restriction and driving simulatorhealthy volonters (control) |
| 3 | Experimental | Other: Chronic sleep restriction and driving simulatoryoung subjects |
| 4 | Experimental | Other: Chronic sleep restriction and driving simulatormature subjects |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy males without snoring nor subjective daytime sleepiness (Epworth <9)
- Intermediate chronotype
- Hypopnea/apnea index <5
- Periodic movement index <5
- Sleep efficiency > 85 %
Key exclusion criteria (13 listed)
- Short or long sleeper
- Shift- or night-worker
- Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders
- Alcohol
- Consumption of illicit drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 1, 2, 3, 4 |
Primary outcome
Standard deviation from the centre of the road on driving simulator
Time frame: 1 week
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Philip, MD principal investigator
University Hospital Bordeaux, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic sleep restriction and driving simulator in people with Sleep Deprivation, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation from the centre of the road on driving simulator (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.