Chronic Sleep Restriction and Driving

Sleep Deprivation Clinical Trial

— PRIVASOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560456
• Other study ID #: CHUBX 2006/09
• Status: Completed
• Phase: N/A
• First received: November 16, 2007
• Last updated: April 19, 2010
• Start date: November 2007
• Est. completion date: October 2009

Study information

• Verified date: April 2010
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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

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 *B1 * A2 *C6

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Bordeaux, Groupe Hospitalier Pellegrin	Bordeaux cedex
France	Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	PREDIT Go4

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard deviation from the centre of the road on driving simulator		1 week	No
Secondary	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	No