Divided Attention Steering Simulator Alertness Test

Study Overview
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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.

Official Title
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Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Other: Divided Attention Steering Simulator (DASS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects capability of giving consent ESS (Epworth Sleepiness scale) score less than 9 Holding a driving license Patients diagnostic OSAS capability of giving consent Holding a driving licence Exclusion Criteria: Healthy subjects suspected OSAS, any observed sleep disorders or snoring acute cardial, pulmonal oder neurological disease Patients - acute cardial, pulmonal oder neurological disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alertness test, sleepiness, vigilance, Sleep Apnea, Obstructive