Trial Review

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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] 314326 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep-disordered breathing 337278 0
Snoring 337279 0
Condition category
Condition code
Respiratory 333676 333676 0 0
Other respiratory disorders / diseases
Respiratory 333677 333677 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, 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] 331066 0
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] 341269 0
Feasibility of use of a novel mattress-sensor device in paediatric sleep medicine.
Timepoint [1] 341269 0
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] 341579 0
Reliability of novel mattress-sensor device recordings
Timepoint [2] 341579 0
Following completion of 14-nights of device setup and attempted recordings
Primary outcome [3] 341580 0
Reliability of oximetry recordings
Timepoint [3] 341580 0
Following completion of 14 nights available for in-home recordings.
Secondary outcome [1] 446978 0
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] 446978 0
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?
No
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
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318845 0
Charities/Societies/Foundations
Name [1] 318845 0
Passe and Williams Foundation
Country [1] 318845 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321295 0
None
Name [1] 321295 0
Address [1] 321295 0
Country [1] 321295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317462 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 317462 0
Ethics committee country [1] 317462 0
Australia
Date submitted for ethics approval [1] 317462 0
04/03/2025
Approval date [1] 317462 0
08/04/2025
Ethics approval number [1] 317462 0
2025/HRE00024

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

Contacts
Principal investigator
Name 141114 0
Prof A. Simon Carney
Address 141114 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 141114 0
Australia
Phone 141114 0
+61 08 8277 0288
Fax 141114 0
Email 141114 0
[email protected]
Contact person for public queries
Name 141115 0
A. Simon Carney
Address 141115 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 141115 0
Australia
Phone 141115 0
+610882770288
Fax 141115 0
Email 141115 0
[email protected]
Contact person for scientific queries
Name 141116 0
Prof. Peter Catcheside
Address 141116 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 141116 0
Australia
Phone 141116 0
+61 08 7421 9164
Fax 141116 0
Email 141116 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 +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.