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Trial registered on ANZCTR


Registration number
ACTRN12614000647639
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
18/06/2014
Date last updated
8/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects and Management of Nocturnal Body Temperature in Children with Cerebral Palsy.
Scientific title
In children with cerebral palsy and reported nocturnal thermoregulation difficulties, is thermoregulation bedding comprising undersheet, oversheet and pillowcover, more effective than sham bedding in improving the child's body temperature, thermal comfort, sleep, activity, participation and quality of life?
Secondary ID [1] 284450 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 291674 0
thermoregulation 291675 0
sleep disturbance 291676 0
activity, participation and quality of life 291677 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292052 292052 0 0
Occupational therapy
Neurological 292053 292053 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thermoregulation bedding (under sheet, over sheet, pillow cover) made of Outlast thermoregulation fabric, with cotton cover; to be used every night for 4 consecutive weeks.
Activity logs, kept by parent or caregiver, will be used to monitor adherence to use of this intervention.
There will be a wash out period of one week, with the child using their own, usual bedding, between use of the intervention bedding and the sham bedding.
Intervention code [1] 289204 0
Treatment: Devices
Comparator / control treatment
The sham bedding (undersheet, oversheet, pillowcover) will be made of the same cotton material as the intervention bedding covers, without the thermoregulation material in place. This will be used every night for 4 consecutive weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 291931 0
Child variation in distal and proximal skin temperature, measured using Thermochron iButtons
Timepoint [1] 291931 0
Measured continuously from one hour before bedtime to wake time, for four consecutive nights.
Primary outcome [2] 291932 0
Child variation in sleep/wake patterns, measured using Actigraph sensors and sleep log.
Timepoint [2] 291932 0
Measured continuously day and night, for four consecutive days/nights.
Primary outcome [3] 291933 0
Child: Quality of Life, measured using CPQoL Questionnaire.
Timepoint [3] 291933 0
Measured at beginning of the first bedding phase, and at the end of each of the two bedding phases (ie, three time points).
Secondary outcome [1] 307855 0
Child core body temperature, measured using infra red tympanic membrane thermometer.
Timepoint [1] 307855 0
Measured one hour before bedtime, at bedtime and on morning waking, for four consecutive nights.
Secondary outcome [2] 307859 0
Child: goals for activity and participation, measured using Canadian Occupational Performance Measure with Goal Attainment Scale.
Timepoint [2] 307859 0
Measured at the beginning of the first bedding phase and at the end of both bedding phases (three time points).
Secondary outcome [3] 307860 0
Caregiver sleep and quality of life; measured using Pittsburgh Sleep Quality Index and Iowa Fatigue Scale
Timepoint [3] 307860 0
Measured at the beginning of the fist bedding phase, and at the end of both bedding phases (three time points).
Secondary outcome [4] 307861 0
Child thermal comfort, measured using thermal comfort report chart
Timepoint [4] 307861 0
Measured one hour before bed, at bedtime and on waking for four consecutive nights.

Eligibility
Key inclusion criteria
Children will be included in the study if they:
1. have a diagnosis of cerebral palsy
2. have difficulty every night with thermoregulation during sleep (self report, or noted by caregiver to appear too hot, too sweaty)
3. are expected to sleep in their usual bed for 5/7 nights for 8 consecutive weeks
4. are expected to sleep in their usual bed for 4 consecutive nights (Monday to Thursday) in Week 2 and Week 5 of the study period
Minimum age
6 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded from the study if they
1.have a current infection or illness such as ear infection, chest infection, cold or flu
2. have epilepsy that is not controlled by medication, or
3. are very restless during sleep, and are considered likely to rub their skin (in case of losing an iButton skin temperature logger)

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)
Participants will be recruited through advertisement to client group of children who receive therapy services from service provider/s in Perth, Western Australia.
Allocation to groups will be made by person other than the researcher, using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used to create the random order for the allocation of subjects into groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Measures of dependant variables (sleep, body temperatures, thermal comfort) will be compared between the bedding intervention and control conditions over consecutive nights and the entire 4 week period using separate two-way repeated-measures ANOVAs. Where a significant interaction effect is found, Bonferroni’s post-hoc test will be used to determine where the differences lie. Statistical tests will be conducted using SPSS version 17.0 (Chicago, Illinois). All results will be expressed as mean +/- SD. The alpha level will be set at p<0.05.
Measures of children’s and caregivers’ activity, participation and quality of life will be compared between the bedding intervention and sham conditions using separate Friedman two-way ANOVAs by ranks. These non-parametric statistics will be performed due to the nature of the assessments (ranked scores and categories). Where a significant interaction effect is found, Bonferroni’s post-hoc test will be used to determine where the differences lie. Statistical tests will be conducted using SPSS version 17.0 (Chicago, Illinois). In addition, the individual % change between control and intervention conditions, as well as the clinical change, measured as change of 2 points in COPM, and as change in scored level in GAS will be examined. All results will be expressed as mean +/- SD. The alpha level will be set at p<0.05.
Because there is currently no reported information on which to base power analysis for number of participants, this has been decided on the basis of clinical samples. A post hoc power analysis will be undertaken of the first 10 participants of the study, to determine if additional subjects and/or time points are required.

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)
WA

Funding & Sponsors
Funding source category [1] 289099 0
University
Name [1] 289099 0
Edith Cowan University
Address [1] 289099 0
270 Joondalup Drive
Joondalup
Western Australia 6027
Country [1] 289099 0
Australia
Funding source category [2] 300359 0
Other Collaborative groups
Name [2] 300359 0
Centre for Research Excellence in Cerebral Palsy
Address [2] 300359 0
Melbourne Children's Research Institute
Flemington Road, Parkville Victoria 3052
Country [2] 300359 0
Australia
Funding source category [3] 300360 0
Charities/Societies/Foundations
Name [3] 300360 0
Freshwater Bay Rotary Club
Address [3] 300360 0
16 Brockway Road
Mt Claremont, Western Australia 6010
Country [3] 300360 0
Australia
Funding source category [4] 300361 0
Commercial sector/Industry
Name [4] 300361 0
Honda Foundation (Honda North)
Address [4] 300361 0
The Honda Foundation
Locked bag 25
Tullamarine, Victoria, 3043
Country [4] 300361 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup
Western Australia 6027
Country
Australia
Secondary sponsor category [1] 287760 0
Hospital
Name [1] 287760 0
Princess Margaret Children's Hospital
Address [1] 287760 0
Roberts Road
Subiaco
Western Australia, 6008
Country [1] 287760 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290885 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 290885 0
270 Joondalup Drive
Joondalup
Western Australia 6027
Ethics committee country [1] 290885 0
Australia
Date submitted for ethics approval [1] 290885 0
Approval date [1] 290885 0
29/01/2014
Ethics approval number [1] 290885 0
10626MCCABE

Summary
Brief summary
Children with Cerebral Palsy (CP) have complex sleep issues and a higher incidence of sleep disturbance than typically developing children. Sleep disturbance has serious impact on their physical and mental health, development, daytime function and well-being, and that of their caregivers. Although management of body temperature is frequently identified as an issue affecting sleep of children with CP, there is no reported information to guide clinical practice in this area.

The primary purpose of this research is to determine the effects of thermoregulation materials which are used to manage body temperature during sleep of children with CP.

This study will measure the effects of specialised bedding on thermoregulation during sleep of children with CP and will be conducted as an intervention study. In a cross over randomised design, children with CP who have sleep and thermoregulation problems will be randomly assigned to begin a four week trial period using either the intervention bedding or the control (sham bedding). This will be followed by an immediate reversed sham or thermoregulation intervention period for four weeks. Measures of body temperature, thermal comfort, perspiration, and sleep, will be taken during each phase. Measures of children’s and caregivers’ activity, participation and quality of life will be taken at the start and at the end of each phase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47778 0
Ms Susan McCabe
Address 47778 0
Edith Cowan University School of Medical and Health Sciences. 270 Joondalup Drive Joondalup, WA 6027
Country 47778 0
Australia
Phone 47778 0
+61 0403285855
Fax 47778 0
Email 47778 0
sue.mccabe7@gmail.com
Contact person for public queries
Name 47779 0
Ms Susan McCabe
Address 47779 0
Edith Cowan University
School of Exercise and Health Sciences
270 Joondalup Drive
Joondalup, WA 6027
Country 47779 0
Australia
Phone 47779 0
+61 0403285855
Fax 47779 0
Email 47779 0
sue.mccabe7@gmail.com
Contact person for scientific queries
Name 47780 0
Ms Susan McCabe
Address 47780 0
Edith Cowan University
School of Exercise and Health Sciences
270 Joondalup Drive
Joondalup, WA 6027
Country 47780 0
Australia
Phone 47780 0
+61 0403285855
Fax 47780 0
Email 47780 0
sue.mccabe7@gmail.com

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