Text Size

Divided Attention Steering Simulator Alertness Test (DASS)

This study has been completed.
Sponsor:
Collaborator:
Reinhard Löwenstein-Stiftung
Information provided by (Responsible Party):
Georg Nilius, Helios Klinik Ambrock
ClinicalTrials.gov Identifier:
NCT01460173
First received: October 25, 2011
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Institut für Pneumologie Hagen Ambrock eV:

Primary Outcome Measures:
  • Standard deviations [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.


Secondary Outcome Measures:
  • Reaction time [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    Reaction time to randomly appearing target numbers to which the subject has to respond.


Enrollment: 200
Study Start Date: February 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460173

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

No publications provided

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
Study First Received: October 25, 2011
Last Updated: September 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Pneumologie Hagen Ambrock eV:
alertness test
sleepiness
vigilance
Sleep Apnea, Obstructive

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013