Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
13/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
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
Country [1] 1207 0
Australia
Funding source category [2] 1208 0
Government body
Name [2] 1208 0
NSW Biofirst Award
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
[email protected]
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
[email protected] au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePerformance of an automated algorithm to process artefacts for quantitative EEG analysis during a simultaneous driving simulator performance task.2017https://dx.doi.org/10.1016/j.ijpsycho.2017.08.004
EmbaseBrain bioenergetics during resting wakefulness are related to neurobehavioral deficits in severe obstructive sleep apnea: A 31P magnetic resonance spectroscopy study.2018https://dx.doi.org/10.1093/sleep/zsy117
EmbaseSleep EEG microstructure is associated with neurobehavioural impairment after extended wakefulness in obstructive sleep apnea.2021https://dx.doi.org/10.1007/s11325-020-02066-5
N.B. These documents automatically identified may not have been verified by the study sponsor.