Divided Attention Steering Simulator Alertness Test | NCT01460173

Studies
Divided Attention Steering Simulator Alertness Test

NCT01460173

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Status

Completed

Last Update Posted

Sep 25, 2012Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Sleep Apnea, Obstructive

Interventions

Divided Attention Steering Simulator (DASS)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Oct 25, 2011

First Posted Date

Oct 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2012

Last Update Posted Date

Sep 25, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georg Nilius, Head of pneumological department of Helios Klinik Hagen Ambrock, Helios Klinik AmbrockPrincipal Investigator

Lead Sponsor

Institut für Pneumologie Hagen Ambrock eVINDUSTRY

Collaborators

Name	Class
Reinhard Löwenstein-Stiftung	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal subjects	Other		Other: Divided Attention Steering Simulator (DASS)
OSA Patients	Other		Other: Divided Attention Steering Simulator (DASS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Reaction time	Reaction time to randomly appearing target numbers to which the subject has to respond.	30 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Nilius, MD	Helios Klinik Hagen Ambrock	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helios Klinik Hagen Ambrock		Hagen	North Rhine-Westphalia	58091	Germany

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D000077260	Sleepiness

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

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Browse Branches

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