RecruitingACTRN12622001544763

Testing a new sleep mat, the Sonomat for use to diagnose sleep breathing problems in children with Neurodisability

Evaluation of a novel sleep mat, the Sonomat, for diagnosis of sleep disordered breathing in children with neurodisability


Sponsor

The University of Queensland

Enrollment

200 participants

Start Date

Feb 6, 2023

Study Type

Interventional

Conditions

Summary

The Sonomat is a non-invasive sleep mat which has recently been validated in children. The primary aim of this study is to evaluate the potential clinical application of the Sonomat, in children with Neurodisability. Participants will undergo sonomat monitoring at the same time as having their in lab sleep study (polysonomgraphy - PSG) and then use the mat at home for three nights. We hypothesise that the sonomat will be comparable to an in lan sleep study for the diagnosis of sleep disordered breathing in children with neurodisability.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Children with neurodisabilities — conditions affecting brain development and function, such as cerebral palsy, Down syndrome, autism spectrum disorder, and ADHD — have a much higher rate of sleep-disordered breathing than other children. Currently, diagnosing these problems requires an overnight sleep study in a hospital, which can be very stressful and difficult for children who may already struggle with new environments and sensory challenges. This study is testing whether a specially designed sleep mat called the Sonomat can accurately detect sleep-disordered breathing in these children at home, making diagnosis much more comfortable and accessible. Participants will undergo their standard in-hospital sleep study while simultaneously lying on the Sonomat, and will then use the mat at home for three nights. Researchers will compare what the Sonomat records with the results of the hospital sleep study to see whether the device is accurate enough to replace the in-hospital test. You may be eligible if your child is aged 2 to 18 years, has a neurodisability meeting the study definition, and has already been referred by a sleep physician for a sleep study to assess sleep-disordered breathing. There are no exclusion criteria for this study.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(3)

Queensland Children's Hospital - South Brisbane

NSW,QLD,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,QLD,VIC, Australia

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ACTRN12622001544763


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