Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001544763
Ethics application status
Approved
Date submitted
29/10/2022
Date registered
13/12/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
13/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new sleep mat, the Sonomat for use to diagnose sleep breathing problems in children with Neurodisability
Scientific title
Evaluation of a novel sleep mat, the Sonomat, for diagnosis of sleep disordered breathing in children with neurodisability
Secondary ID [1] 308303 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 328090 0
neurodisability 328296 0
Condition category
Condition code
Respiratory 325144 325144 0 0
Sleep apnoea
Neurological 325343 325343 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the accuracy of the Sonomat to diagnose Sleep disordered breathing in children with neurodisability. Using the sonomat involves no attached monitoring. The sonomat is a sleep mat that is placed under the participants bed sheet on top of their usual mattress. It contains sensors that detect movement and sound to determine sleep and breathing. For use the Sonomat is placed under the bedsheet before bedtime and plugged in to a power socket. There is a button to turn the mat on and it then switches off after use for a 12hr period. The mat contains an SD card which is downloaded by the study investigators on return and the data is then analysed by a research investigator. The mat does not require any adherence monitoring.

For this study the sonomat will be used concurrently in the sleep lab at the same time as the participant undergoes a sleep study (polysomnography) and then immediately following this PSG night at home for three consecutive nights in the participants own environment. Sonomat testing will be completed whilst the participant is asleep overnight. Ideally at least 6 hours of sleep duration is required. Most children will sleep for an average of 8-10 hours per night.

Within the lab the mat will be placed under the bedsheet by the sleep nurse technician looking after the participant and at home it will be applied by the parent/primary caregiver. The caregiver will have been shown how to use the mat during the sleep study night and also provided with written instructions in order to then undertake the home monitoring directly after the PSG night.

In summary for each participant the sonomat will be used on four occasions- one night in the sleep lab and three consecutive nights at home directly after the PSG night. If participants do not wish to undertake home monitoring, only the sleep lab night will be performed. The first night will be the sleep lab night

Sleep Diary when doing home Sonomat Monitoring
Parent/primary caregivers of the participants will be asked to undertake a sleep diary alongside the home use of the sonomat (for the consecutive three nights). The sleep diary will be recorded concurrently with use of the sonomat for the three home nights of monitoring for the duration of the night whilst the participant is in bed.The Sleep diary will record the day and date of monitoring, bedtime, wake time and comments regarding whether the participant's activities were outside of the normal regular routine for them, whether they got our of bed, woke for parts of the night. The sleep diary used is that which is used for clinical purposes by the primary site (Brisbane). A sleep diary generally takes around 5-10 minutes to complete each night.

Intervention code [1] 324754 0
Diagnosis / Prognosis
Comparator / control treatment
The control is the gold standard diagnostic test of in lab polysomnography (Sleep Study) used to diagnose sleep disordered breathing in children. Sonomat monitoring will occur concurrent to the in lab polysomnography which will be undertaken at one of the three participating tertiary paediatric sleep labs (brisbane, sydney and melbourne) by trained paediatric sleep staff. The procedure undertaken is as per the American Academy of Sleep Medicine standard. The test is conducted by sleep clinical nursing staff/scientists with expertise in applying the equipment involved (EEG, EOG, EMG chin and diaphragm, ECG, CO2 and O2 monitoring, audio and video recording, position sensor). In children sleep studies are currently performed in lab for the duration of at least 6 hours (usually 8-10hours) supervised by a trained paediatric sleep technician or clinical nurse. As a result any misplaced leads can be repositioned through the night
Control group
Active

Outcomes
Primary outcome [1] 332971 0
Agreement between respiratory events form Sonomat and polysomnography (PSG) studies (Apnoea-Hypopnoea Index or AHI measure) using intra-class corerelation coefficient (ICC).
Timepoint [1] 332971 0
Assessed after PSG and Concurrent Sonomat assessment has been completed
Primary outcome [2] 333350 0
Agreement between respiratory events form Sonomat and polysomnography (PSG) studies (Obstructive-Apnoea-Hypopnoea Index or OAHI measure) using intra-class corerelation coefficient (ICC).
Timepoint [2] 333350 0
Assessed after PSG and Concurrent Sonomat assessment has been completed
Secondary outcome [1] 415373 0
Agreement between the Sonomat and PSG for Total Sleep Time (TST) will be recorded by the Sonomat and PSG will be compared using paired student t-test for normally distributed data or Wilcoxon signed-rank test for non-normal data.
Timepoint [1] 415373 0
After PSG and concurrent Sonomat evaluation has been undertaken
Secondary outcome [2] 415374 0
Carer experience questionnaire comparing the Sonomat and PSG - this is a questionnaire specifically designed for this study which has been previously tested in a pilot study involving 60 participants with Down syndrome
Timepoint [2] 415374 0
After PSG and concurrent Sonomat monitoring has been completed
Secondary outcome [3] 415375 0
Agreement between the Sonomat and concurrent sleep diary total sleep time (TST) will be compared using paired student t-test for normally distributed data or Wilcoxon signed-rank test for non-normal data.
Timepoint [3] 415375 0
After both Sonomat and sleep diary assessments have been completed for three consecutive nights at home.
Secondary outcome [4] 416151 0
Environmental measures including average room light levels and temperature will be reported, analysing the data from the three home nights. This will be recorded with a Hobo Data logger- Pendant MX Temperature/Light Data Logger monitor which will be provided to participants when they undertake their home sonomat monitoring.
Timepoint [4] 416151 0
After the three home nights of Sonomat monitoring have been undertaken- Data will be downloaded from the logger using the software provided with the logger and recorded after the. three nights of home monitoring.
Secondary outcome [5] 416152 0
Descriptive statistics will be used to summarise the findings of the room environment following review of the audio and video recordings at home
Timepoint [5] 416152 0
After the three nights of home sonomat monitoring have been completed
Secondary outcome [6] 416697 0
Agreement between the Sonomat and concurrent sleep diary measure for sleep efficiency will be compared using paired student t-test for normally distributed data or Wilcoxon signed-rank test for non-normal data
Timepoint [6] 416697 0
After both Sonomat and sleep diary assessments have been completed for three consecutive nights at home.

Eligibility
Key inclusion criteria
Children aged 2-18yrs who meet the study definition for ND and who have been deemed to require a PSG clinically by a sleep physician, for assessment of Sleep disordered breathing (SDB).

Children with Neurodisability (ND): this research will include all children who meet the ICD-11 definition for a neurodisability. Specific conditions include (but are not limited to) Cerebral Palsy, Down syndrome, Prader-Willi syndrome, Angelman’s syndrome, Velocardiofacial (22q11deletion) syndrome, Rett syndrome, Fragile X syndrome, William’s syndrome, Smith-Magenis Syndrome, Spina Bifida, Autistic Spectrum Disorder and Attention Deficit Hyperactivity Disorder (ADHD). Where there is uncertainty on whether a child meets the criteria, advice will be sought from a neurodevelopmental paediatrician.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be presented for the cohort. Inter-scorer variability for Sonomat and PSG will be assessed independently using the Intra-class correlation coefficient (ICC). Respiratory events and other sleep measures (Total sleep time (TST), sleep efficiency) recorded by the Sonomat and PSG will be compared using paired student t-test for normally distributed data or Wilcoxon signed-rank test for non-normal data. The agreement between the two methods of diagnosing OSA will be assessed using the Cohen’s Kappa. Agreement for continuous measures will be presented using Bland-Altman method and limits of agreement and ICC will be reported. Descriptive statistics will report findings from the carer’s questionnaire

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
6/02/2023
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
154
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 23475 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 23476 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 23477 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 38883 0
4101 - South Brisbane
Recruitment postcode(s) [2] 38884 0
2145 - Westmead
Recruitment postcode(s) [3] 38885 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 312553 0
Government body
Name [1] 312553 0
National Health and Medical Research Council (Medical Research Future Fund)
Country [1] 312553 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia Brisbane, Queensland 4072
Country
Australia
Secondary sponsor category [1] 314156 0
None
Name [1] 314156 0
Address [1] 314156 0
Country [1] 314156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311880 0
Children's Hospital Queensland Hospital and Health Sevice HREC
Ethics committee address [1] 311880 0
Ethics committee country [1] 311880 0
Australia
Date submitted for ethics approval [1] 311880 0
13/10/2022
Approval date [1] 311880 0
20/10/2022
Ethics approval number [1] 311880 0
HREC/22/QCHQ/89813

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

Contacts
Principal investigator
Name 122702 0
A/Prof Jasneek Chawla
Address 122702 0
Department of Paediatric Respiratory and Sleep Medicine
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 122702 0
Australia
Phone 122702 0
+61 452662105
Fax 122702 0
Email 122702 0
[email protected]
Contact person for public queries
Name 122703 0
Andrew Collaro
Address 122703 0
Kids Sleep Research Group - Child Health Research Centre
Level 4 Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane
Queensland 4101
Country 122703 0
Australia
Phone 122703 0
+61 7 30697503
Fax 122703 0
Email 122703 0
[email protected]
Contact person for scientific queries
Name 122704 0
Jasneek Chawla
Address 122704 0
Department of Paediatric Respiratory and Sleep Medicine
Queensland Children's Hospital
501 Stanley Street
South Brisbane
Queensland 4101
Country 122704 0
Australia
Phone 122704 0
+61 7 3069 7503
Fax 122704 0
Email 122704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results only - on request
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years after main publication
Available to whom?
Case by case on request to researchers
Available for what types of analyses?
IPD meta-analyses
if a clear purpose is identifiable on the request
How or where can data be obtained?
By request to the chief investigator by email to [email protected]


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.