Sleep Apnea, ObstructiveDASSNCT01460173
Divided Attention Steering Simulator Alertness Test
A study testing Divided Attention Steering Simulator (DASS) in people with Sleep Apnea, Obstructive, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Divided Attention Steering Simulator (DASS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Healthy subjects
- suspected OSAS, any observed sleep disorders or snoring
- acute cardial, pulmonal oder neurological disease
- Patients - acute cardial, pulmonal oder neurological disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios Klinik Hagen Ambrock
Hagen, North Rhine-Westphalia, 58091
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Divided Attention Steering Simulator (DASS)
- Keywords
- alertness test, sleepiness, vigilance, Sleep Apnea, Obstructive
- Medical subject headings
- Sleep Apnea, Obstructive, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Other | Not described Receives: Other: Divided Attention Steering Simulator (DASS) |
| OSA Patients | Other | Not described Receives: Other: Divided Attention Steering Simulator (DASS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviations
Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.
Measured: 30 minutes
Secondary outcomes (1)
Reaction time
Reaction time to randomly appearing target numbers to which the subject has to respond.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reinhard Löwenstein-Stiftung
- Responsible party
- Principal investigator, Georg Nilius, Helios Klinik Ambrock
- Investigators
- Georg Nilius, MD, Principal investigator, Helios Klinik Hagen Ambrock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460173
- Sponsor's protocol ID
- DASS2011
- Acronym
- DASS
- Status last verified
- Sep 2012
- First submitted
- 25 Oct 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aufmerksamkeitstest Mittels Fahrsimulation Bei Normalpersonen Und Patienten Mit Obstruktivem Schlafapnoesyndrom
- ClinicalTrials.gov ID
- NCT01460173
- Acronym / sponsor ID
- DASS / DASS2011
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- alertness test, sleepiness, vigilance, Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- Reinhard Löwenstein-Stiftung
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | Other | Other: Divided Attention Steering Simulator (DASS) |
| OSA Patients | Other | Other: Divided Attention Steering Simulator (DASS) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy subjects
- Patients
Key exclusion criteria (4 listed)
- Healthy subjects
- Patients - acute cardial, pulmonal oder neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, OSA Patients |
Primary outcome
Standard deviations
Time frame: 30 minutes
Steering performance is quantified as the standard deviation of the error from a theoretical perfect path.
1 secondary outcome
Reaction time
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Nilius, MD principal investigator
Helios Klinik Hagen Ambrock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Divided Attention Steering Simulator (DASS) in people with Sleep Apnea, Obstructive, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviations (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.