Divided Attention Steering Simulator Alertness Test

Sleep Apnea, Obstructive Clinical Trial

— DASS  

Official title:

Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460173
• Other study ID #: DASS2011
• Status: Completed
• Phase: N/A
• First received: October 25, 2011
• Last updated: September 24, 2012
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

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).

Locations

Country	Name	City	State
Germany	Helios Klinik Hagen Ambrock	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	Reinhard Löwenstein-Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard deviations	Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.	30 minutes	No
Secondary	Reaction time	Reaction time to randomly appearing target numbers to which the subject has to respond.	30 min	No