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
ACTRN12608000504314
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
30/09/2008
Date last updated
8/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep disruption in quadriplegia – A pilot study exploring whether 3mg melatonin induces sleep
Scientific title
Pilot study examining whether daily administration of 3mg melatonin alters sleep architecture in complete quadriplegia
Secondary ID [1] 262805 0
H2010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unrefreshing sleep 3695 0
Condition category
Condition code
Respiratory 3860 3860 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two week within subject (pre-post) trial of evening administration of 3mg melatonin delivered orally
Intervention code [1] 3408 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4763 0
Rapid Eye Movement (REM) sleep latency measured using portable polysomnography
Timepoint [1] 4763 0
Baseline and two weeks
Secondary outcome [1] 8043 0
Sleepiness (Karolinska Sleepiness Scale)
Timepoint [1] 8043 0
Baseline and two weeks
Secondary outcome [2] 8044 0
Salivary melatonin concentrations
Timepoint [2] 8044 0
Baseline and two weeks. Measures made immediately prior to melatonin administration, at participants usual sleep time (2 hours later) and upon awakening the next morning

Eligibility
Key inclusion criteria
Complete (motor and sensory) quadriplegia (T1 or higher lesion)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major psychological or psychiatric disturbances, Neurological damage other than spinal cord injury, Other significant co-morbidity, Beta blockers.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
1/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3942 0
Other Collaborative groups
Name [1] 3942 0
Institute for breathing and sleep
Country [1] 3942 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Country
Australia
Secondary sponsor category [1] 3544 0
None
Name [1] 3544 0
Country [1] 3544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6016 0
Austin Hospital Human Research Ethics Unit
Ethics committee address [1] 6016 0
Ethics committee country [1] 6016 0
Australia
Date submitted for ethics approval [1] 6016 0
Approval date [1] 6016 0
03/09/2008
Ethics approval number [1] 6016 0
H2008/03303

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

Contacts
Principal investigator
Name 28936 0
A/Prof David Berlowitz
Address 28936 0
Bowen Centre Austin Health. Studley Rd Heidelberg 3084
Country 28936 0
Australia
Phone 28936 0
061394963871
Fax 28936 0
Email 28936 0
david.berlowitz@austin.org.au
Contact person for public queries
Name 12093 0
David Berlowitz
Address 12093 0
Institute for Breathing and Sleep Bowen Centre. Austin Health Studley Rd. Heidelberg Vic 3084
Country 12093 0
Australia
Phone 12093 0
0394963688
Fax 12093 0
Email 12093 0
david.berlowitz@austin.org.au
Contact person for scientific queries
Name 3021 0
David Berlowitz
Address 3021 0
Institute for Breathing and Sleep Bowen Centre. Austin Health Studley Rd. Heidelberg Vic 3084
Country 3021 0
Australia
Phone 3021 0
0394963688
Fax 3021 0
Email 3021 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.