Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000672055
Ethics application status
Approved
Date submitted
13/08/2010
Date registered
17/08/2010
Date last updated
3/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of a modified Oxford Sleep Resistance Test (OSLER-2) and switches in healthy able-bodied participants
Scientific title
Study examining the performance on the Oxford Sleep Resistance Test (OSLER-2) when using the standard hand-held response switch compared to two non-hand held response switches as a measure of daytime sleepiness in able-bodied participants.
Secondary ID [1] 252414 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Validation of OSLER-2 switches as measure of daytime sleepiness 257920 0
Sleep disturbances 257951 0
Daytime sleepiness 257952 0
Condition category
Condition code
Neurological 258094 258094 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three testing days with each day testing one type of switch: 1) standard OSLER-2 hand-held switch (requires a finger tap); 2) "Magic wand-pad" switch (requires a chin tap); 3) "jelly-bean" switch (requires a head tap). The order in which switches are tested will be randomised and counterbalanced. Participants taking the OSLER-2 test sit comfortably in a darkened room and press a switch in response to a small light presented for one second every three seconds for forty minutes. The OSLER-2 will be performed four times per testing day (9:30, 11:30, 13:30, 15:30). Each testing day is separated by 1-8 weeks. On the night before each testing day, sleep is restricted to a maximum of three hours.
Intervention code [1] 256978 0
Other interventions
Intervention code [2] 257021 0
Diagnosis / Prognosis
Comparator / control treatment
Performance on the standard OSLER-2 using the hand-held response switch
Control group
Active

Outcomes
Primary outcome [1] 258954 0
Measure of daytime sleepiness by the OSLER-2 using each of the three switches
Timepoint [1] 258954 0
OSLER-2 test performed four times a day (9:30, 11:30, 13:30. 15:30) over three testing days, one for each switch. Testing days will be separated by at least a week
Secondary outcome [1] 265121 0
Nil
Timepoint [1] 265121 0
Nil

Eligibility
Key inclusion criteria
Healthy able-bodied participants
No diagnosis of a sleep disorder
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Visual problems not corrected by glasses/contact lenses,
Psychiatric or Neurological disorders,
Addiction to nicotine or excessive smoking of cigarettes,
Use of benzodiazapines,
Recent travel across time zones or planned travel across time zones during protocol,
Being a shift worker

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257431 0
University
Name [1] 257431 0
University of Melbourne
Country [1] 257431 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne, VIC 3010
Country
Australia
Secondary sponsor category [1] 256661 0
Hospital
Name [1] 256661 0
Institute for Breathing and Sleep, Austin Health
Address [1] 256661 0
PO Box 5555, Studley Rd, Heidelberg, VIC 3084
Country [1] 256661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259450 0
Austin Health Ethics Commitee
Ethics committee address [1] 259450 0
Studley Rd, Heidelberg. Vic 3084
Ethics committee country [1] 259450 0
Australia
Date submitted for ethics approval [1] 259450 0
Approval date [1] 259450 0
05/07/2010
Ethics approval number [1] 259450 0
H2010/03932

Summary
Brief summary
The OSLER-2 is a common test which objectively measures daytime sleepiness. A limitation of the OSLER-2 test, however, is that it can only be performed by people who do not have hand or arm disabilities as it involves feedback to the presentation of a light via a hand-held response box. Our group has modified an OSLER-2 to accept responses from switches that do not require hand function, switches which are commonly used within the quadriplegia population. This research aims to examine the relationships between the modified switch OSLER-2 against the standard hand-held switch OSLER-2 as a measure of daytime sleepiness in able-bodied, sleep restricted people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31497 0
Address 31497 0
Country 31497 0
Phone 31497 0
Fax 31497 0
Email 31497 0
Contact person for public queries
Name 14744 0
Jayne Roberts
Address 14744 0
Institute for Breathing and Sleep
Bowen Centre
Austin Health
Studley Road
Heidelberg
VIC 3084
Country 14744 0
Australia
Phone 14744 0
+613 9496 3517
Fax 14744 0
Email 14744 0
jayne.roberts@austin.org.au
Contact person for scientific queries
Name 5672 0
David Berlowitz
Address 5672 0
Institute for Breathing and Sleep
Bowen Centre
Austin Health
Studley Road
Heidelberg
VIC 3084
Country 5672 0
Australia
Phone 5672 0
+613 9496 3871
Fax 5672 0
Email 5672 0
david.berlowitz@austin.org.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
No additional documents have been identified.