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Trial registered on ANZCTR


Registration number
ACTRN12606000066583
Ethics application status
Approved
Date submitted
14/02/2006
Date registered
16/02/2006
Date last updated
11/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Power spectral analysis and inverse modeling of the electroencephalogram to monitor sleepiness on a driving simulator during sleep deprivation
Scientific title
The effect of 40 hours sleep deprivation on sleepiness, driving simulator performance and electrographic power in healthy volunteers and patients with obstructive sleep apnea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea. 1029 0
Healthy volunteers also studied. 1030 0
Condition category
Condition code
Respiratory 1104 1104 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleep deprivation 40 hours
Intervention code [1] 895 0
None
Comparator / control treatment
non-sleep deprived state (measured at baseline before 40-hour sleep deprivation period, time = zero hours)
Control group
Active

Outcomes
Primary outcome [1] 1471 0
Subjective sleepiness.
Note that the key aim is to model the progression of the outcomes across the 40 hour intervention period.
Timepoint [1] 1471 0
Measured every 2 hours during study.
Secondary outcome [1] 2639 0
Driving simulator performance
Timepoint [1] 2639 0
Measured every 2 hours.
Secondary outcome [2] 2640 0
Quantitative electroencephalography measures
Timepoint [2] 2640 0
Measured every 2 hours.

Eligibility
Key inclusion criteria
Healthy group: n = 12 without sleep disorder.OSA group: n = 12.
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of hypnotics, head injury or neurological conditions, use of drugs known to affect central nervous system.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1207 0
Other Collaborative groups
Name [1] 1207 0
RACP-CONROD Fellowship
Address [1] 1207 0
x
Country [1] 1207 0
Australia
Funding source category [2] 1208 0
Government body
Name [2] 1208 0
NSW Biofirst Award
Address [2] 1208 0
x
Country [2] 1208 0
Australia
Primary sponsor type
Individual
Name
Naomi Rogers
Address
Country
Secondary sponsor category [1] 1067 0
Individual
Name [1] 1067 0
Delwyn Bartlett
Address [1] 1067 0
x
Country [1] 1067 0
Australia
Secondary sponsor category [2] 1068 0
Individual
Name [2] 1068 0
Keith Wong
Address [2] 1068 0
x
Country [2] 1068 0
Australia
Secondary sponsor category [3] 1069 0
Individual
Name [3] 1069 0
Nathaniel Marshall
Address [3] 1069 0
x
Country [3] 1069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2548 0
Sydney South West Area Health Service (Eastern Zone)
Ethics committee address [1] 2548 0
Ethics committee country [1] 2548 0
Australia
Date submitted for ethics approval [1] 2548 0
Approval date [1] 2548 0
01/08/2005
Ethics approval number [1] 2548 0
X05-0165
Ethics committee name [2] 2549 0
University of Sydney
Ethics committee address [2] 2549 0
Ethics committee country [2] 2549 0
Australia
Date submitted for ethics approval [2] 2549 0
Approval date [2] 2549 0
02/02/2006
Ethics approval number [2] 2549 0
8609

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35251 0
Address 35251 0
Country 35251 0
Phone 35251 0
Fax 35251 0
Email 35251 0
Contact person for public queries
Name 10084 0
Sarah Newton-John
Address 10084 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10084 0
Australia
Phone 10084 0
+61 2 95156578
Fax 10084 0
+61 2 95505865
Email 10084 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 1012 0
Dr Keith Wong
Address 1012 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 1012 0
Australia
Phone 1012 0
+61 2 95158981
Fax 1012 0
+61 2 9515 7070
Email 1012 0
keithw@med.usyd.edu au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary