NCT00560456

Brief 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 subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

1.9 years

First QC Date

November 16, 2007

Last Update Submit

April 19, 2010

Conditions

Sleep Deprivation

Keywords

Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness

Outcome Measures

Primary Outcomes (1)

  • Standard deviation from the centre of the road on driving simulator

    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

    1 week

Study Arms (4)

1

EXPERIMENTAL

snorers

Other: Chronic sleep restriction and driving simulator

2

OTHER

healthy volonters (control)

Other: Chronic sleep restriction and driving simulator

3

EXPERIMENTAL

young subjects

Other: Chronic sleep restriction and driving simulator

4

EXPERIMENTAL

mature subjects

Other: Chronic sleep restriction and driving simulator

Interventions

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

1234

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Sleep DeprivationSnoring

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersRespiratory SoundsSigns and Symptoms, Respiratory

Study Officials

  • Pierre Philip, MD

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

November 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations

FR(2)