Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000734965
Ethics application status
Yes
Date submitted
13/07/2011
Date registered
13/07/2011
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Melatonin for Sleep Disturbance Following Traumatic Brain Injury
Scientific title
Efficacy of Melatonin for Sleep Disturbance Following Traumatic Brain Injury
Secondary ID [1] 262424 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The primary health condition to be investigated is sleep disturbance in individuals who have sustained a traumatic brain injury. 268115 0
A secondary health condition is to investigate depression and anxiety. 268116 0
Condition category
Condition code
Neurological 268258 268258 0 0
Other neurological disorders
Mental Health 268259 268259 0 0
Depression
Mental Health 268260 268260 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Circadin melatonin 2mg prolonged release tablet is be taken orally after food and 1-2 hours prior to going to bed. Participants will be required to consume each of the respective treatments for a total of 8 weeks. Treatment intervention will commence at week 3 after the baseline run in period. As this a crossover study, the active melatonin treatment may be administered at either the first or second treatment intervention with each intervention 4 weeks in duration. The frist treatment intervention will commence at week 3 and end at week 6, with the second treatment intervention commencing at week 7 and finishing at week 10.
Intervention code [1] 266797 0
Treatment: drugs
Intervention code [2] 266974 0
Other interventions
Comparator / control treatment
The control formulation is made of Methocel E4M Premium 66mg and Micocrystalline cellulose 88mg. This formulaiton is be taken orally after food and 1-2 hours prior to going to bed.
Participants will be required to consume each of the respective treatments for a total of 8 weeks. Treatment intervention will commence at week 3 after the baseline run in period. As this a crossover study, the placebo treatment may be administered at either the first or second treatment intervention with each intervention 4 weeks in duration. The frist treatment intervention will commence at week 3 and will end at week 6, with the second treatment intervention commencing at week 7 and finishing at week 10.
Control group
Placebo

Outcomes
Primary outcome [1] 268985 0
Sleep onset latency and sleep quality.
Timepoint [1] 268985 0
Sleep onset latency will be measured continuously throughout the trial over the 10 week period via Actigraphy. Sleep quality will be assessed every morning throughout the 10 week period via a questionnaire that participants will be required to fill in.
Secondary outcome [1] 276753 0
Depression and Anxiety will be assessed with the use of paper and pen Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 276753 0
Depression and Anxiety will be assessed at four time points. The first takes place on their baseline assessment (week 0). The second takes place at the end of the baseline run-in period (week 2). The third at the end of treatment one (Week 6). The fourth at the end of treatment two (week 10).
Secondary outcome [2] 276754 0
General health and well being will be assessed with the use of a papper and pen questionnaire namely the SF-36 Health Related Quality of Life Questionnaire (SF-36).
Timepoint [2] 276754 0
General health and Well being will be assessed at four time points. The first takes place on their baseline assessment (week 0). The second takes place at the end of the baseline run-in period (week 2). The third at the end of treatment one (Week 6). The fourth at the end of treatment two (week 10).

Eligibility
Key inclusion criteria
>Individuals who have sustained a Traumatic Brain Injury (TBI)
>Able to understand and converse in English
>Adequate cognitive and physical ability to complete questionnaires
>Adequate visual acuity determined by their ability to read questionnaires
>TBI patients with mild to severe TBI who have sustained blunt head trauma with loss of consciousness as determined by an initial Glasgow Coma Scale of 3-15 OR a period of post-traumatic amnesia (PTA)
>TBI patients with reported sleep difficulties as determined by a Pittsburgh sleep quality index greater or equal to a score of 9.
>Sustained head injury between 3-12 months prior to their participation in the study
Patients currently taking Psychiatric medications will be allowed to participate.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
>Pittsburgh sleep quality index less than a score of 9.
>History of other neurological problems prior to head trauma
> Have travelled across more than 1 time zone in the preceding 3 months
> Have worked night shift in the preceding 3 months
>History of sleep disturbance prior to head trauma which required treatment
>History of Chronic fatigue requiring treatment prior to head trauma.
>BMI greater than 30
>Requiring surgery expected to occur during their participation in the trial
>current or previous history of illicit drug usage
> Women who are breast feeding
>Currently taking psychotropic medication which includes benzodiazepines or hypnotics.
> Currently taking Psycho stimulant drugs
> Currently taking complimentary medicines to treat sleep disturbance.

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)
Prospective TBI participants who report sleep disturbances and fulfil other selection criteria will be informed of the study by their treating rehabilitation physician. The rehabilitation physician will determine if the study is suitable for their patients. All participants will need to seek approval from their treating rehabilitation physician in order to participate in the trial. TBI patients who are suitable candidates will be referred to a research assistant who will screen them further to determine if they fulfil inclusion criteria. Participants who satisfy selection criteria will be encouraged to discuss their participation with family, friends and other doctors who are not involved in the study. Participants who are interested in the trial will be scheduled for their first visit. The rehabilitation physician will prescribe the treatments to their patients such that they will approve treatment to commence. The TBI patients, rehabilitation physician, research assistant, pharmacy personal dispensing the treatments will all be blinded to the treatment conditions such that they will not be aware of which treatment is which.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 271046 0
State/province [1] 271046 0

Funding & Sponsors
Funding source category [1] 267267 0
University
Name [1] 267267 0
Monash University
Country [1] 267267 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
School of Psychology and Psychiatry.
Building 17
Clayton Campus,
Wellington Road,
Clayton, Victoria,
Australia,
3800.
Country
Australia
Secondary sponsor category [1] 266327 0
Hospital
Name [1] 266327 0
Epworth HealthCare
Address [1] 266327 0
Epworth Corporate, 89 Bridge Road, Richmond, Victoria, Australia, 3121.
Country [1] 266327 0
Australia
Secondary sponsor category [2] 266492 0
None
Name [2] 266492 0
Address [2] 266492 0
Country [2] 266492 0

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 269286 0
Epworth Healthcare Human Research Ethics Committee
Ethics committee address [1] 269286 0
Ethics committee country [1] 269286 0
Australia
Date submitted for ethics approval [1] 269286 0
01/06/2011
Approval date [1] 269286 0
25/06/2011
Ethics approval number [1] 269286 0
52111
Ethics committee name [2] 269412 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 269412 0
Ethics committee country [2] 269412 0
Australia
Date submitted for ethics approval [2] 269412 0
22/06/2011
Approval date [2] 269412 0
Ethics approval number [2] 269412 0
2011001061

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

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

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.