Trial Review

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
ACTRN12609000714280
Ethics application status
Approved
Date submitted
12/08/2009
Date registered
19/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep disruption in quadriplegia, its hormonal basis and a randomized controlled trial (RCT) of melatonin supplementation
Scientific title
Study examining whether daily administration of 3mg melatonin alters subjective sleep experience and sleep architecture in people with complete quadriplegia
Secondary ID [1] 262162 0
H2009/03579
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic complete quadriplegia 243502 0
Unrefreshed sleep 243510 0
Condition category
Condition code
Neurological 239806 239806 0 0
Other neurological disorders
Respiratory 239808 239808 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 week within subject trial of daily evening administration of 3mg melatonin delivered orally. Randomised, double-blind, placebo controlled trial with two-week washout period between intervention and placebo treatments
Intervention code [1] 241121 0
Treatment: Drugs
Comparator / control treatment
3 week within subject daily evening administration of placebo 3mg soft shell gelatin capsule delivered orally
Control group
Placebo

Outcomes
Primary outcome [1] 240613 0
Improved subjective sleep experience measured by a daily sleep diary and the Basic Nordic Sleepiness Questionnaire and the Sleep Disturbance Severity Scale
Timepoint [1] 240613 0
Baseline and 3, 5, and 8 weeks after randomisation
Secondary outcome [1] 257249 0
Improved phasing of sleep as measured by polysomnography
Timepoint [1] 257249 0
Baseline and 3, 5, and 8 weeks after randomisation
Secondary outcome [2] 257250 0
Improved Quality of life as measured by the Assessment of Quality of Life Questionnaire, the Hospital Anxiety Depression Scale and the Profile of Moods States
Timepoint [2] 257250 0
Baseline and 3, 5, and 8 weeks after randomisation
Secondary outcome [3] 257251 0
Improved autonomic functioning as assessed by a portable blood pressure and heart rate monitor, Orthostatic Hypotension Questionnaire and urine catecholamine and electrolyte levels
Timepoint [3] 257251 0
Baseline and 3, 5, and 8 weeks after randomisation

Eligibility
Key inclusion criteria
Complete (motor and sensory) quadriplegia (T1 or higher lesion), time since spinal cord injury is greater than one year (chronic)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Travel across three or more time zones within three weeks or during protocol, Pregnancy or breast feeding, Ongoing use of over-the-counter melatonin

Study design
Purpose of the study
Treatment
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
25/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237496 0
Charities/Societies/Foundations
Name [1] 237496 0
Victorian Neurotrauma Initiative
Country [1] 237496 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 236978 0
None
Name [1] 236978 0
Address [1] 236978 0
Country [1] 236978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239616 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 239616 0
P.O. Box 5555
Heidelberg
Victoria 3084
Ethics committee country [1] 239616 0
Australia
Date submitted for ethics approval [1] 239616 0
Approval date [1] 239616 0
07/08/2009
Ethics approval number [1] 239616 0

Summary
Brief summary
People with complete quadriplegia commonly report sleep disturbances and have been found to lack melatonin production, a hormone that modulates our sleep cycle. It is unclear if their sleep problems are related to their lack of melatonin production. The aim of this study was to investigate whether nightly supplementation of 3mg melatonin would induce, shift the phase of and/or modify subjective sleep for people with complete quadriplegia. It is hypothesised that supplementation with melatonin will improve subjective sleep for people with complete quadriplegia along with their sleep phasing, quality of life and autonomic functioning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30044 0
Address 30044 0
Country 30044 0
Phone 30044 0
Fax 30044 0
Email 30044 0
Contact person for public queries
Name 13291 0
Jo Spong
Address 13291 0
Institute for Breathing and Sleep
Bowen Centre
Austin Health
Studley Road
Heidelberg
Victoria 3084
Country 13291 0
Australia
Phone 13291 0
+61 3 9496 3877
Fax 13291 0
Email 13291 0
[email protected]
Contact person for scientific queries
Name 4219 0
Jo Spong
Address 4219 0
Institute for Breathing and Sleep
Bowen Centre
Austin Health
Studley Road
Heidelberg
Victoria 3084
Country 4219 0
Australia
Phone 4219 0
+61 3 9496 3877
Fax 4219 0
Email 4219 0
[email protected]

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.