Divided Attention Steering Simulator Alertness Test (DASS)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive	Other: Divided Attention Steering Simulator (DASS)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Official Title:	Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom
Study Start Date :	February 2011
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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).
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).

Outcome Measures

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Primary Outcome Measures :

1. Standard deviations [ Time Frame: 30 minutes ]
   Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.

Secondary Outcome Measures :

1. Reaction time [ Time Frame: 30 min ]
   Reaction time to randomly appearing target numbers to which the subject has to respond.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Institut für Pneumologie Hagen Ambrock eV

Reinhard Löwenstein-Stiftung

Investigators

Principal Investigator:	Georg Nilius, MD	Helios Klinik Hagen Ambrock

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Georg Nilius, Head of pneumological department of Helios Klinik Hagen Ambrock, Helios Klinik Ambrock
ClinicalTrials.gov Identifier:	NCT01460173 History of Changes
Other Study ID Numbers:	DASS2011
First Posted:	October 26, 2011
Last Update Posted:	September 25, 2012
Last Verified:	September 2012

Keywords provided by Georg Nilius, Helios Klinik Ambrock:

alertness test; sleepiness; vigilance; Sleep Apnea, Obstructive

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Respiration Disorders; Respiratory Tract Diseases	Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases