NCT00849706

Brief Summary

Long and unorthodox working hours (e.g. 24 hours or 23pm-07am shifts for doctors and nurses respectively) combined with sleep deprivation, may affect cognitive functions such as response time and concentration. These parameters may be tested using a driving simulator. Apart from the obvious consequences of driving skills impairment for the medical personal, it may serve as a quality assessment tool in evaluating the impact of workload and sleep deprivation on medical staff's function. This study aims to assess the effect of work load and sleep deprivation on medical staff's driving skills.

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

February 19, 2009

Last Update Submit

February 23, 2009

Conditions

Keywords

sleep deprivationworkloadincreased workload

Outcome Measures

Primary Outcomes (1)

  • Change in driving simulator test results after night shifts compared with control.

    2 months

Study Arms (1)

Study group

Medical staff personal, doctors and nurses, working night shifts.

Other: Study participants will work their regular shifts, and tested after night shifts.No shifts will be added because of the study.

Interventions

Night shifts in our medical center are working 8 hours from 23:00 to 7:00 the following day for nurses, and working overnight (24h) for doctors.

Study group

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Medical staff (doctors and nurses) working night shifts.

You may qualify if:

  • Given informed consent
  • Medical staff (doctor / nurse) working night shifts.
  • Having a driver's license.

You may not qualify if:

  • Pregnancy.
  • Any systemic / neurological condition which may affect results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Ein-Kerem, POB 12000, Israel

Location

Related Publications (2)

  • Bajaj JS, Hafeezullah M, Hoffmann RG, Varma RR, Franco J, Binion DG, Hammeke TA, Saeian K. Navigation skill impairment: Another dimension of the driving difficulties in minimal hepatic encephalopathy. Hepatology. 2008 Feb;47(2):596-604. doi: 10.1002/hep.22032.

    PMID: 18000989BACKGROUND
  • Horne J, Reyner L. Vehicle accidents related to sleep: a review. Occup Environ Med. 1999 May;56(5):289-94. doi: 10.1136/oem.56.5.289.

    PMID: 10472301BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 24, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations