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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep-disordered breathing

Snoring

Airway obstruction during sleep

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Respiratory

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]

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]

Feasibility of use of a novel mattress-sensor device in paediatric sleep medicine

Timepoint [1]

Analysis at the end of 14 nights of data from at-home use of the mattress and oximetry devices and diary

Primary outcome [2]

Reliability of novel mattress-sensor device recordings

Timepoint [2]

Analysis at the end of 14 nights of data from at-home use of the mattress device and diary

Primary outcome [3]

Reliability of oximetry recordings

Timepoint [3]

Analysis at the end of 14 nights of data from at-home use of the oximetry device and diary

Secondary outcome [1]

nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Passe and Williams Foundation

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders University Human Research Ethics Committee

Ethics committee address [1]

https://staff-projects.flinders.edu.au/research-support/integrity/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2024

Approval date [1]

09/04/2025

Ethics approval number [1]

8110

Summary

Brief summary

Polysomnography (PSG) remains as the gold standard for diagnosing sleep-disordered breathing in children as it provides comprehensive monitoring of cardiac, respiratory, musculoskeletal, and neurological functions. However, the procedure’s requirement for overnight hospital stays and skilled personnel poses significant challenges including long wait times, high costs and difficulties in reflecting daily sleep patterns due to the unnatural sleeping environment. Alternatives like smartphone videos and overnight oximetry, though more accessible, lack diagnostic accuracy.
This study aims to address these limitations, by introducing a minimally invasive on-mattress device capable of recording body position, acoustic, respiratory and cardiac signals, with oximetry data (via a pulse oximeter) to identify breathing issues during sleep.
We hypothesise that this device will simplify and improve the diagnosis of sleep-disordered breathing in children.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof A. Simon Carney

Address

Flinders University, Sturt Road, Bedford Park, SA 5042

Country

Australia

Phone

+610882770288

Fax

[email protected]

Contact person for public queries

Name

A. Simon Carney

Address

Flinders University, Sturt Road, Bedford Park, SA 5042

Country

Australia

Phone

+610882770288

Fax

[email protected]

Contact person for scientific queries

Name

Prof. Peter Catcheside

Address

Flinders University, Sturt Road, Bedford Park, SA 5042

Country

Australia

Phone

+61 08 7421 9164

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
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.

Trial Review

Documents added manually

Documents added automatically