NCT01460173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

October 25, 2011

Last Update Submit

September 24, 2012

Conditions

Sleep Apnea, Obstructive

Keywords

alertness testsleepinessvigilanceSleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • Standard deviations

    Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.

    30 minutes

Secondary Outcomes (1)

  • Reaction time

    30 min

Study Arms (2)

Normal subjects

OTHER
Other: Divided Attention Steering Simulator (DASS)

OSA Patients

OTHER
Other: Divided Attention Steering Simulator (DASS)

Interventions

Divided Attention Steering Simulator (DASS)OTHER

Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).

Normal subjectsOSA Patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Healthy subjects
  • suspected OSAS, any observed sleep disorders or snoring
  • acute cardial, pulmonal oder neurological disease
  • Patients - acute cardial, pulmonal oder neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleepiness

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georg Nilius, MD

    Helios Klinik Hagen Ambrock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of pneumological department of Helios Klinik Hagen Ambrock

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 26, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

DE(1)