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Divided Attention Steering Simulator Alertness Test

NCT ID: NCT01460173

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive

Keywords

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alertness test sleepiness vigilance Sleep Apnea, Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Normal subjects

Group Type OTHER

Divided Attention Steering Simulator (DASS)

Intervention Type OTHER

Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).

OSA Patients

Group Type OTHER

Divided Attention Steering Simulator (DASS)

Intervention Type OTHER

Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reinhard Löwenstein-Stiftung

UNKNOWN

Sponsor Role collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role lead

Responsible Party

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Georg Nilius

Head of pneumological department of Helios Klinik Hagen Ambrock

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen Ambrock

Locations

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Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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DASS2011

Identifier Type: -

Identifier Source: org_study_id