Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000606482
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a novel mattress device to record sleep-disordered breathing in children
Scientific title
Testing a novel mattress device to record sleep-disordered breathing in paediatric patients
Secondary ID [1] 314318 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep-disordered breathing 337270 0
Snoring 337271 0
Airway obstruction during sleep 337272 0
Condition category
Condition code
Respiratory 333670 333670 0 0
Other respiratory disorders / diseases
Respiratory 333671 333671 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a novel mattress sensor device and a finger pulse oximeter ring device for up to 14 nights in the home will provide comparative observational data for comparisons between devices across multiple nights in paediatric patients with clinical signs and symptoms of sleep disordered breathing.

The mattress sensor device is a long, thin, flat sensor strip that is placed on top of the mattress under the chest of the person lying in bed. The bed sensor is placed under the mattress protector and bottom bed sheet so there is no physical contact with the study participant. The sensor connects to a low-voltage USB-powered device placed next to the bed (e.g. on a bedside table or floor), which also contains acoustic and environmental condition (light, temperature and humidity) sensors. The device is triggered to record when the bed sensor detects movement (body movements and respiratory movements) and continuously captures respiratory related motion and acoustic data when movement is present. Users can very easily turn the device off to prevent recordings if they wish.

The finger pulse oximeter device is a wrist device with finger probe that is securely taped onto a suitable finger tip (one of the most reliable vascular beds for oximetry) prior to sleep. Trial participants will be asked to use the oximeter on at least on one night during the 14 nights at home, but preferably more often. Data are stored on onto the wrist device for subsequent download and off-line analysis of conventional oximetry metrics (average levels, oxygen desaturation indices and hypoxic burden).

Participants and their parent will have a 30 minute face-to-face meeting with researchers where the devices will be shown and instructions given on their use. Instructional materials, including trouble-shooting guides and contact details for support if required will also be provided.

The parent will be asked to complete a brief daily diary to record if the devices were used the previous night and any issues that arose.

If the participant does undergo upper airway surgery after participating in the 14 at-home nights, there is an option to repeat the 14 nights at home with the two devices once recovered from the surgery. This will be an opt-in choice by the parent and participant. These preliminary observational data will be used to test the sensitivity of novel device measures to standard care surgical interventions, with oximetry as a useful comparator control.
Intervention code [1] 331064 0
Diagnosis / Prognosis
Comparator / control treatment
Overnight oximetry respiratory disturbance metrics will be compared with device detected respiratory disturbance metrics. Both measures are observational and will not influence usual clinical care of study participants. These preliminary data will help to determine the strength of anticipated relationships between non-intrusive bed sensor measurements and oximetry, which requires a device to be worn each night.

The finger pulse oximeter device is a wrist device with finger probe that is securely taped onto a suitable finger tip (one of the most reliable vascular beds for oximetry) prior to sleep. Trial participants will be asked to use the oximeter on at least on one night during the 14 nights at home, but preferably more often. Data are stored on onto the wrist device for subsequent download and off-line analysis of conventional oximetry metrics (average levels, oxygen desaturation indices and hypoxic burden).
Control group
Active

Outcomes
Primary outcome [1] 341263 0
Feasibility of use of a novel mattress-sensor device in paediatric sleep medicine
Timepoint [1] 341263 0
Analysis at the end of 14 nights of data from at-home use of the mattress and oximetry devices and diary
Primary outcome [2] 341476 0
Reliability of novel mattress-sensor device recordings
Timepoint [2] 341476 0
Analysis at the end of 14 nights of data from at-home use of the mattress device and diary
Primary outcome [3] 341477 0
Reliability of oximetry recordings
Timepoint [3] 341477 0
Analysis at the end of 14 nights of data from at-home use of the oximetry device and diary
Secondary outcome [1] 446957 0
nil
Timepoint [1] 446957 0
nil

Eligibility
Key inclusion criteria
*parents willing and capable of providing informed consent prior to any screening or study specific procedure
*willing to participate in the designated follow up visits
*paediatric patients under age of 12
*history of snoring and/or sleep disordered breathing requiring ENT assessment for consideration of adenotonsillar surgery
Minimum age
No limit
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
significant clinician identified comorbidities making them unable or inappropriate to participate in this study

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
This is a pilot observational study to determine the feasibility and reliability of novel mattress sensor device measurements in a paediatric clinical population in which novel measures may have future clinically utility. Statistics will be descriptive, to describe the study population characteristics, count data to describe the number of successful versus failed recordings, and exploratory of relationships between novel non-intrusive device measures versus more conventional worn sensor oximetry metrics. Preliminary data will also importantly inform future study design choices and sample size selection which require knowledge regarding the nature of the currently unknown distribution of novel metrics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
5/10/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318840 0
Charities/Societies/Foundations
Name [1] 318840 0
Passe and Williams Foundation
Country [1] 318840 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321288 0
None
Name [1] 321288 0
none
Address [1] 321288 0
Country [1] 321288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317457 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 317457 0
Ethics committee country [1] 317457 0
Australia
Date submitted for ethics approval [1] 317457 0
26/11/2024
Approval date [1] 317457 0
09/04/2025
Ethics approval number [1] 317457 0
8110

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

Contacts
Principal investigator
Name 141094 0
Prof A. Simon Carney
Address 141094 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 141094 0
Australia
Phone 141094 0
+610882770288
Fax 141094 0
Email 141094 0
[email protected]
Contact person for public queries
Name 141095 0
A. Simon Carney
Address 141095 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 141095 0
Australia
Phone 141095 0
+610882770288
Fax 141095 0
Email 141095 0
[email protected]
Contact person for scientific queries
Name 141096 0
Prof. Peter Catcheside
Address 141096 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 141096 0
Australia
Phone 141096 0
+61 08 7421 9164
Fax 141096 0
Email 141096 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    PISCF for Paediatric Mattress Device Study V4 (01APR2025) - Clean.pdf
Informed consent form    HREC - Child or Lay Language PICF V2 (01APR2025)-Clean.pdf


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.