Trial from ANZCTR


Trial ID ACTRN12610000009011
Trial Status: Registered
Date Submitted: 5/01/2010
Date Registered: 6/01/2010
Retrospectively registered

Page 1

Public title Experimental Investigations of Driving Impairment in Obstructive Sleep Apnoea
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Treatment: Other 255754 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Steering Deviation (deviations in median lane position of the virtual road measured in centimeters) will be assessed via computerised driving simulator and analysis software 257529 0
Update:
 
Reason:
 
Timepoint: Baseline and aproximately 3 months 257529 0
Update:
 
Reason:
 
Primary Outcome: Crashes (including off-road events, stopping events and truck collisions) will be assessed via computerised driving simulator and analysis software 257542 0
Update:
 
Reason:
 
Timepoint: Baseline and aproximately 3 months 257542 0
Update:
 
Reason:
 
Primary Outcome: 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 257543 0
Update:
 
Reason:
 
Timepoint: Baseline and aproximately 3 months 257543 0
Update:
 
Reason:
 
Secondary Outcome: Epworth Sleepiness Scale assessed vian questionnaire 262759 0
Update:
 
Reason:
 
Timepoint: Baseline and 3 months 262759 0
Update:
 
Reason:
 

Page 5

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.
Update:
 
Reason:
 
Minimum age 25 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age 70 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
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
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Educational / counselling / training
Update:
 
Allocation to intervention Nonrandomised trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) N/A
Update:
 
Reason:
 
Masking / blinding
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment
Update:
 
Reason:
 
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)
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/03/2006
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 180
Update:
 
Reason:
 
Recruitment status Closed: follow-up complete
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 
Postcode: 5041 2375 0
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Government body 256240 0
Update:
 
Reason:
 
Name: National Health and Medical Research Council 256240 0
Update:
 
Reason:
 
Address: GPO Box 1421 Canberra ACT 2601 256240 0
Update:
 
Reason:
 
Country: Australia 256240 0
Update:
 
Reason:
 
Primary Sponsor Government body
Update:
 
Reason:
 
Name: National Health and Medical Research Council
Update:
 
Reason:
 
Address: GPO Box 1421 Canberra ACT 2601
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: Hospital 251570 0
Update:
 
Reason:
 
Name: Adelaide Institute for Sleep Health 251570 0
Update:
 
Reason:
 
Address: Repatriation General Hospital,
Daws Road, Daw Park
SA, 5041
251570 0
Update:
 
Reason:
 
Country: Australia 251570 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Repatriation General Hospital Research and Ethics Committee 258331 0
Update:
 
Reason:
 
Address: Repatriation General Hospital,
Daws Road, Daw Park, SA 5041
258331 0
Update:
 
Reason:
 
Country: Australia 258331 0
Update:
 
Reason:
 
Approval Date: 28/03/2007 258331 0
Update:
 
Reason:
 
Submitted Date: 01/06/2006 258331 0
Update:
 
Reason:
 
HREC: 6/06/2010 258331 0
Update:
 
Reason:
 
Ethics Committee name: The University of Adelaide Human Reseach Ethics Committee 258332 0
Update:
 
Reason:
 
Address: Level 7, 115 Grenfell Street , The University of Adelaide, SA 5005 258332 0
Update:
 
Reason:
 
Country: Australia 258332 0
Update:
 
Reason:
 
Approval Date: 31/05/2006 258332 0
Update:
 
Reason:
 
Submitted Date: 01/03/2006 258332 0
Update:
 
Reason:
 
HREC: H-035-2006 258332 0
Update:
 
Reason:
 
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
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

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

Contact person for scientific queries
Title:
Update:
 
Reason:
 
4833 0
Name: Doug McEvoy
Update:
 
Reason:
 
4833 0
Address: Adelaide Insititute for Sleep Health, Repatriation General Hospital Daws Road, Daw Park, SA 5041
Update:
 
Reason:
 
4833 0
Country: Australia
Update:
 
4833 0
Reason:
 
Tel: +61 8 8275 1187
Update:
 
Reason:
 
4833 0
Fax:
Update:
 
Reason:
 
4833 0
Email: doug.mcevoy@health.sa.gov.au
Update:
 
Reason:
 
4833 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
22977 0
Name:
Update:
 
Reason:
 
22977 0
Address:
Update:
 
Reason:
 
22977 0
Country:
Update:
 
22977 0
Reason:
 
Tel:
Update:
 
Reason:
 
22977 0
Fax:
Update:
 
Reason:
 
22977 0
Email:
Update:
 
Reason:
 
22977 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: