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Trial registered on ANZCTR

Registration number

ACTRN12625000605493

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

Comparing a novel mattress sensor with overnight in-laboratory sleep studies to assess sleep-disordered breathing in children

Scientific title

Comparing a novel mattress device with polysomnography to assess 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

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, and during one night of in-laboratory polysomnography (PSG) will provide comparative observational data to guide future larger scale trials 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. Downloaded device data will also be used to evaluate the number of successful device recordings (mattress sensor and oximeter devices) as a percentage of the number of nights available for recordings.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Overnight oximetry and mattress sensor device respiratory disturbance metrics in the home and in the laboratory will be compared to single night in-laboratory polysomographic measures of sleep disturbances. The additional mattress and oximetry 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.

Control group

Active

Outcomes

Primary outcome [1]

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

Timepoint [1]

Daily device recordings over 14 nights of data collection will be used to determine the proportion of study participants in whom any successful device recordings were obtained in the home setting.

Primary outcome [2]

Reliability of novel mattress-sensor device recordings

Timepoint [2]

Following completion of 14-nights of device setup and attempted recordings

Primary outcome [3]

Reliability of oximetry recordings

Timepoint [3]

Following completion of 14 nights available for in-home recordings.

Secondary outcome [1]

Mattress sensor device sleep related respiratory disturbance metrics versus conventional in-laboratory respiratory disturbance rates as conventionally determined using the apnoea hypopnea index.

Timepoint [1]

Following completion of the single night conentional in-laboratory polysmnography study.

Eligibility

Key inclusion criteria

1. Aged 2-7 years inclusive
2. History of snoring and/or sleep disordered breathing
3. Ability for non-contested parental consent
4. Ability to attend for follow-up consultation

Minimum age

2 Years

Maximum age

7 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Potential life-threatening obstruction requiring urgent ENT intervention
2. Guardianship issues, legal consent orders or any concerns regarding safety of parental consent
3. BMI >30 kg/m²
4. Major paediatric issues (e.g. syndromic diagnoses, craniofacial issues, diabetes, hypertension, congenital cardiac problems, severe respiratory disease etc).
5. Living > 25km from Metropolitan Adelaide (for logistics of device collection).
6. Inability to adequately complete PSG at the Women's and Children's Hospital
7. Previous nasal, adenoid or tonsil surgery
8. Previous upper airway surgery (non-ENT)
9. Impractical to fit the mattress device to the bed mattress at home

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

Statistics will be descriptive and exploratory in nature.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

7/07/2025

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]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

https://www.wchn.sa.gov.au/research/human-research

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/03/2025

Approval date [1]

08/04/2025

Ethics approval number [1]

2025/HRE00024

Summary

Brief summary

Polysomnography (PSG) currently remains the gold standard for diagnosing sleep-disordered breathing in children as it provides comprehensive monitoring of cardiac, respiratory, musculoskeletal, and neurological functions during sleep. However, paediatric PSG requires a 1-night in hospital stay with extensive instrumentation with multiple wires and sensors setup and monitored by skilled personnel. This process poses significant challenges that include long wait times, child and parental distress from the procedures and unnatural sleeping environment, high costs and problems of extrapolating 1-night PSG results to usual sleep at home. Alternatives like smartphone videos and overnight oximetry, though more accessible, lack diagnostic sensitivity, specificity and accuracy.

This study aims to address these limitations by introducing a minimally intrusive on-mattress device capable of recording body position, acoustic, respiratory and cardiac signals, along with oximetry data (via a pulse oximeter) to identify breathing issues during sleep in the normal home sleeping environment. Following successful proof-of-concept trials in adults, this study seeks to pilot test the use of this device in children to assess potential clinical utility, feasibility and reliability compared to PSG and overnight oximetry in paediatric sleep medicine care.

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

+61 08 8277 0288

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 +PSG Study V3_23Apr2025_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