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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
Gender
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
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] 3942 0
Other Collaborative groups
Name [1] 3942 0
Institute for breathing and sleep
Address [1] 3942 0
Studley Rd, Heidelberg 3084 Vic
Country [1] 3942 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Rd, Heidelberg 3084 Vic
Country
Australia
Secondary sponsor category [1] 3544 0
None
Name [1] 3544 0
Address [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
Research Ethics Unit
Level 8 HSB - Room 8322
Austin hospital.
PO Box 5555 Heidelberg Vic 3084
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
This study will collect preliminary, pilot data regarding the feasibility and utility of supplemental melatonin to treat delayed sleep in quadriplegia
Trial website
Trial related presentations / publications
Spong J, Kennedy GA, Brown DJ, Armstrong SM & Berlowitz D. Melatonin supplementation in patients with complete tetraplegia and poor sleep. Sleep Disorders. 2013. Vol 2013 (Article ID 128197) 8 pages.doi:1155/2013/128197
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
A/Prof 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
A/Prof 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
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