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Trial registered on ANZCTR


Registration number
ACTRN12619001585112p
Ethics application status
Submitted, not yet approved
Date submitted
11/11/2019
Date registered
18/11/2019
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Treatment for Post-Concussion Clinical Insomnia in Children and Adolescents: The Effect of Melatonin Plus Sleep Hygiene Education Versus Education Alone
Scientific title
A Randomised Controlled Trial of Treatment for Post-Concussion Clinical Insomnia in Children and Adolescents: The Effect of Melatonin Plus Sleep Hygiene Education Versus Education Alone
Secondary ID [1] 299776 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Concussion Clinical Insomnia 315144 0
Condition category
Condition code
Neurological 313460 313460 0 0
Other neurological disorders
Injuries and Accidents 313502 313502 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of two treatment groups for a duration of 4 weeks: sleep hygiene education (standard care) or sleep hygiene education plus melatonin (intervention). Participants randomised to the intervention group will be given a prescription for melatonin supply and instructed on its administration. Melatonin will be given in wafer form and administered sublingually, with a dosage of either 3mg, 6mg or 9mg depending on participant size. Participants will be instructed to take melatonin 1 hour before retiring during the 4 week intervention period. The Sleep Hygiene Index (assessed on a weekly basis) and a sleep diary will be given to participants, monitoring their adherence to engaging in sleep-promoting behaviours during the intervention period. The sleep diary also includes a question on supplement intake to assist with sleep, which allows compliance to melatonin to be measured.
Intervention code [1] 316033 0
Behaviour
Comparator / control treatment
Sleep hygiene education involves a standard information resource (usual care) (https://kidshealth.schn.health.nsw.gov.au/sites/default/files/concussion_aftercare_-sleep_infosheet_2018.pdf) that is given to the participant and explained to them face-to-face by a member of the research team for a duration of 15-20 minutes, on a weekly basis during the study period (4 weeks). This advises and informs the participant of sleep-promoting behaviours they should be engaging in to improve their sleep disturbance. All treatment groups will receive this as it is standard care.
Control group
Active

Outcomes
Primary outcome [1] 321933 0
Concussion recovery time (days). Number of participants with a prolonged recovery (concussion recovery time > 4 weeks).
Timepoint [1] 321933 0
Throughout the entire study period. The study endpoint is clinical and physiological recovery from concussion as determined by the treating clinician (maximum time point: 6 months).
Primary outcome [2] 321934 0
Post Concussion Clinical Insomnia (PCCI) will be assessed via the Insomnia Severity Index (ISI). Number and proportion of patients with ISI score reduction of 5 or more points from baseline at each assessment point until injury recovery. Number of patients whose PCCI has significantly improved by ISI score reduction of < 6 points from baseline or resolved to ISI score <= 7 within four weeks of injury. Treatment failure based on need for sleep medicine, subspecialist referral, or an unchanged ISI score >= 14.
Timepoint [2] 321934 0
Baseline and at weekly time points until recovered (maximum time point: 6 months).
Secondary outcome [1] 376729 0
Symptom burden will be assessed via the Post Concussion Symptom Score (PCSS). Number and proportion of patients with a reduction in the PCSS by 5 points from baseline at each assessment point until injury recovery.
Timepoint [1] 376729 0
Baseline and at weekly time points until the participant has recovered (maximum time point: 6 months).
Secondary outcome [2] 376731 0
Objective mean sleep specific variables (sleep onset latency, total sleep time, wake after sleep onset, and sleep efficiency) measured via actigraphy.
Timepoint [2] 376731 0
All participants will wear an Actiwatch (Philips Respironics Actiwatch 2) for 14 consecutive days during the first two weeks of the treatment period.
Secondary outcome [3] 376734 0
Exercise tolerance will be measured via graded exercise treadmill testing using the Bruce Protocol.
Timepoint [3] 376734 0
Baseline and at weekly time points until recovered (maximum time point: 6 months).

Eligibility
Key inclusion criteria
- Children and adolescent youth aged 8-17 years with a diagnosed concussion;
- Patients with sleep disturbance defined by an Insomnia Severity Index (ISI) > 7;
- Patients with a concussive injury presenting to the Kids Concussion Service (KCS) at the Children's Hospital Institute of Sports Medicine (CHISM).
Minimum age
8 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with:
- No to minimal sleep disturbance (defined by ISI<7);
- Pre-injury chronic sleep disorder;
- Complex sleep disorder determined from sleep questionnaires;
- Neurological disorder unrelated to concussive injury;
- Attention Deficit Hyperactivity Disorder (ADHD);
- Chronic behavioural disorder;
- Psychiatric condition.

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)
Upon presentation to the Kids Concussion Service (KCS) at the Children's Hospital Institute of Sports Medicine (CHISM) and following routine treatment, eligible participants will be identified by the staff specialist/investigator. The investigator will ask the potential participant and their parent/caregiver whether they would be interested in taking part in the study and provide an explanation of what is involved. Each participant and their parent/caregiver will also be given a copy of the participant information sheet.

Randomisation will be performed by a researcher who is not involved in the recruitment or testing of participants. The participant’s group will be enclosed in a sealed, opaque envelope. Allocation concealment will be maintained using the sealed, opaque envelopes that are not opened until after the participant is recruited and consented. Treatment allocations and the preparation of envelopes will be made by a researcher not associated with the study. Investigators conducting the weekly physical and cognitive assessment will be blinded to group allocations. The investigator conducting the clinical examination will not be blinded to group allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed separately within each exercise tolerance cohort using a computerised randomisation generator, accessed at www.randomization.com, using permuted blocks to maintain balance. There are no other prognostic factors believed to be important for stratification of the randomisation. Randomisation will be performed by a researcher who is not involved in the recruitment or testing of participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 15133 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 28427 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304241 0
Hospital
Name [1] 304241 0
The Children's Hospital Institute of Sports Medicine
Address [1] 304241 0
Suite 13, Level 2
Children's Hospital Medical Centre Hainsworth Street
Westmead NSW 2145
Country [1] 304241 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital Institute of Sports Medicine
Address
Suite 13, Level 2
Children's Hospital Medical Centre Hainsworth Street
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 304483 0
University
Name [1] 304483 0
The University of Sydney
Address [1] 304483 0
The University of Sydney
Cumberland Campus
75 East Street
Lidcombe NSW 2141
Country [1] 304483 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304700 0
Sydney Children's Hospital Network (SCHN) Human Research Ethics Committee
Ethics committee address [1] 304700 0
Corner Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Sydney Australia
Ethics committee country [1] 304700 0
Australia
Date submitted for ethics approval [1] 304700 0
04/11/2019
Approval date [1] 304700 0
Ethics approval number [1] 304700 0

Summary
Brief summary
Despite sleep problems being one of the most common symptoms experienced following concussion in children and adolescents, there is little scientific evidence for its treatment. Therefore, this study aims to determine: 1) the basic characteristics of sleep disturbance in children and adolescents following concussion; 2) the impact of post-concussion clinical insomnia (PCCI) on recovery; and 3) if the addition of melatonin to sleep education can improve patient outcome.
Only children and adolescents with sleep disturbance following concussion, aged 8-17 years, will be eligible to participate in the study. Eligible participants will be randomly allocated to either Treatment Group 1 (i.e. sleep hygiene education) or Treatment Group 2 (i.e. sleep hygiene education plus melatonin) for a duration of 4 weeks, and will be monitored throughout this period until they have recovered.
The findings from this study will facilitate a better understanding of the nature of sleep problems in children and adolescents following concussion, and will also provide scientific evidence of whether current interventions are effective in their treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97918 0
Prof Gary Browne
Address 97918 0
Suite 13, Level 2
Children's Hospital Medical Centre Hainsworth Street
Westmead NSW 2145
Country 97918 0
Australia
Phone 97918 0
+61 02 9845 0761
Fax 97918 0
Email 97918 0
gary.browne@health.nsw.gov.au
Contact person for public queries
Name 97919 0
Ms Maree Cassimatis
Address 97919 0
Suite 13, Level 2
Children's Hospital Medical Centre Hainsworth Street
Westmead NSW 2145
Country 97919 0
Australia
Phone 97919 0
+61 02 9845 0761
Fax 97919 0
Email 97919 0
mcas9964@uni.sydney.edu.au
Contact person for scientific queries
Name 97920 0
Ms Maree Cassimatis
Address 97920 0
Suite 13, Level 2
Children's Hospital Medical Centre Hainsworth Street
Westmead NSW 2145
Country 97920 0
Australia
Phone 97920 0
+61 02 9845 0761
Fax 97920 0
Email 97920 0
mcas9964@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results