Trial registered on ANZCTR


Trial ID
ACTRN12610000009011
Ethics application status
Approved
Date submitted
5/01/2010
Date registered
6/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Experimental Investigations of Driving Impairment in Obstructive Sleep Apnoea
Scientific title
An uncontrolled trial comparing the effects of sleep restriction and alcohol on driving simulator performance in obstructive sleep apnoea (OSA) patients versus matched controls and evaluating the effectiveness of continuous positive air-way pressure (CPAP) treatment in improving driving simulator performance in obstructive sleep apnoea (OSA) patients
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 256470 0
Condition category
Condition code
Respiratory 256637 256637 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Initial baseline evaluation of driving simulator performance will be performed in patients with obstructive sleep apnoea and matched healthy subjects under three conditions of normal sleep, restricted sleep (4 hrs) and alcohol (0.05 g/dL) in a random order one week apart. Patients will then undergo a laboratory based countinuous positive air-way pressure (CPAP) titration study, issued a CPAP machine and encouraged to use it as much as possibe but at least 4 hours per night for a minimum of 3 month. Control subjects were not on any treatment and were asked to continue their normal activities.
Intervention code [1] 255754 0
Treatment: Other
Comparator / control treatment
3 months follow-up driving simulator assessments under the three conditions of normal sleep, sleep restriction and alcohol. Control participants will not be on any treatment for three months, but will be followed-up and driving will be also assessed at 3 months.
Control group
Active

Outcomes
Primary outcome [1] 257529 0
Steering Deviation (deviations in median lane position of the virtual road measured in centimeters) will be assessed via computerised driving simulator and analysis software
Timepoint [1] 257529 0
Baseline and aproximately 3 months
Primary outcome [2] 257542 0
Crashes (including off-road events, stopping events and truck collisions) will be assessed via computerised driving simulator and analysis software
Timepoint [2] 257542 0
Baseline and aproximately 3 months
Primary outcome [3] 257543 0
Braking Reaction Time (measured as the speed of a braking in response to suddenly appearing trucks ahead of the virtual car) will be assessed via computerised driving simulator and analysis software
Timepoint [3] 257543 0
Baseline and aproximately 3 months
Secondary outcome [1] 262759 0
Epworth Sleepiness Scale assessed vian questionnaire
Timepoint [1] 262759 0
Baseline and 3 months

Eligibility
Key inclusion criteria
Aged 25-70 years
At least 2 OSA symptoms (snoring, choking arousals or witnessed apneas, excessive daytime sleepiness)
Full Diagnostic polysomnogram showing an apnea/hypopnea index >15 events/hr, central apnea index <5/hr
untreated for OSA
Live in Adelaide (not country patients)
Full private standard driving license, drive at least 2 hours per week and have been driving in Australia for at least 2 years.
Minimum age
25 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of significant head injury
History of alcohol or drug abuse
History of central nervous system disease (e.g. past history of stroke)
Current use of medication which may affect driving (e.g. sedating antihistamines and opiates, regular use of hypnotics and other sedating psychotropic or anticonvulsant medication)
Sleep disorders such as narcolepsy, periodic limb movement disorder, restless legs syndrome, insomnia
Significant medical co-morbidities likely to affect sleep (e.g. severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in the first second (FEV1) <50%, significant cardiac failure (New York Heart Association [NYHA] 3 or 4), major depression).
Professional drivers
Night shiftworkers

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligable patients diognosed with OSA (aonea-hypopnea inderx of >15 events/hour) were identified and recruited following a diognostic sleep study at Adelaide Institute for Sleep Health. Healthy age matched control volunteers were recruited following from the general population using news paper advertisements and screened for eligability by a diognostic sleep study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
repeated measures in 2 groups with 3 conditions in a random order at basline and following 3 months of CPAP treatment (follow-up)
Phase
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/03/2006
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
180
Actual sample size
Recruitment status
Closed: follow-up complete
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2375 0
5041

Funding & Sponsors
Funding source category [1] 256240 0
Government body
Name [1] 256240 0
National Health and Medical Research Council
Address [1] 256240 0
GPO Box 1421 Canberra ACT 2601
Country [1] 256240 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO Box 1421 Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 251570 0
Hospital
Name [1] 251570 0
Adelaide Institute for Sleep Health
Address [1] 251570 0
Repatriation General Hospital,
Daws Road, Daw Park
SA, 5041
Country [1] 251570 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258331 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 258331 0
Repatriation General Hospital,
Daws Road, Daw Park, SA 5041
Ethics committee country [1] 258331 0
Australia
Date submitted for ethics approval [1] 258331 0
01/06/2006
Approval date [1] 258331 0
28/03/2007
Ethics approval number [1] 258331 0
6/06/2010
Ethics committee name [2] 258332 0
The University of Adelaide Human Reseach Ethics Committee
Ethics committee address [2] 258332 0
Level 7, 115 Grenfell Street , The University of Adelaide, SA 5005
Ethics committee country [2] 258332 0
Australia
Date submitted for ethics approval [2] 258332 0
01/03/2006
Approval date [2] 258332 0
31/05/2006
Ethics approval number [2] 258332 0
H-035-2006

Summary
Brief summary
This study will compare the effects of common "lifestyle" factors of sleep loss and alcohol on driving simulator performance in patients with obstructive sleep apnoea and healthy subjects and evaluate the effectiveness of continuous positive air-way pressure treatment in improving driving simulator performance
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30658 0
Address 30658 0
Country 30658 0
Phone 30658 0
Fax 30658 0
Email 30658 0
Contact person for public queries
Name 13905 0
Doug McEvoy
Address 13905 0
Adelaide Insititute for Sleep Health,
Repatriation General Hospital
Daws Road, Daw Park, SA 5041
Country 13905 0
Australia
Phone 13905 0
+61 8 8275 1187
Fax 13905 0
Email 13905 0
doug.mcevoy@health.sa.gov.au
Contact person for scientific queries
Name 4833 0
Doug McEvoy
Address 4833 0
Adelaide Insititute for Sleep Health,
Repatriation General Hospital
Daws Road, Daw Park, SA 5041
Country 4833 0
Australia
Phone 4833 0
+61 8 8275 1187
Fax 4833 0
Email 4833 0
doug.mcevoy@health.sa.gov.au