Divided Attention Steering Simulator Alertness Test (DASS)

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: Sleep Apnea, Obstructive
• Intervention / Treatment: Other: Divided Attention Steering Simulator (DASS)

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: Institut für Pneumologie Hagen Ambrock eV
• Collaborators: Reinhard Löwenstein-Stiftung
• Investigators: Principal Investigator: Georg Nilius, MD, Helios Klinik Hagen Ambrock

Study record dates

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: Sleep Apnea, Obstructive; sleepiness; vigilance; alertness test
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: DASS2011