Divided Attention Steering Simulator Alertness Test (DASS)

September 24, 2012 updated by: Georg Nilius, Institut für Pneumologie Hagen Ambrock eV

Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom

Driving simulator programmes are used under a wide range of conditions, and a correlation of driving performance and real accident risks in patients with obstructive sleep apnoea syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today there are no reference levels with regards to sex and age in existence. To define the boundaries of normality age and sex reference values are to be generated and compared to values of patients with OSAS.

50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as well. A better differentiation of pathologic driving performance and response times of OSAS patients should be possible with new reference levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The DASS programme records several data, including mean and absloute errors and standard deviations from centre and curve.

Additionally the response time to a randomly appearing target number is recorded (divided attention).

The standard deviation (curve) is the difference between the steering angle and the road angle. Standard deviation (centre) is the standard deviation of the centre of the car from the centre of the road.

Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.

The secondary task of the divided attention test is to respond to a randomly appearing target number at the sides of the monitor while trying to keep the car in the centre of the road.

Average Reaction time is the average time (in seconds) it takes the subject to respond to the target numbers.

Study Type

Interventional

Enrollment (Actual)

200

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

  • Germany
    • NRW
      • Hagen, NRW, Germany, 58091
        • Helios Klinik Hagen Ambrock

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

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subjects

    • capability of giving consent
    • ESS (Epworth Sleepiness scale) score less than 9
    • Holding a driving license

  2. Patients

    • diagnostic OSAS
    • capability of giving consent
    • Holding a driving licence

Exclusion Criteria:

  1. Healthy subjects

    • suspected OSAS, any observed sleep disorders or snoring
    • acute cardial, pulmonal oder neurological disease
  2. Patients - acute cardial, pulmonal oder neurological disease

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

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: OSA Patients
Other: Divided Attention Steering Simulator (DASS)
Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).
Other: Normal subjects
Other: Divided Attention Steering Simulator (DASS)
Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard deviations
Time Frame: 30 minutes
Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction time
Time Frame: 30 min
Reaction time to randomly appearing target numbers to which the subject has to respond.
30 min

Collaborators and Investigators

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

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Collaborators

Reinhard Löwenstein-Stiftung

Investigators

  • Principal Investigator: Georg Nilius, MD, Helios Klinik Hagen Ambrock

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

February 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

September 25, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DASS2011

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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