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Testing a novel mattress device to record sleep-disordered breathing in children

Testing a novel mattress device to record sleep-disordered breathing in paediatric patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000606482
Enrollment
20
Registered
2025-06-12
Start date
2025-06-23
Completion date
2026-10-05
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 b

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
No minimum to 12 Years
Healthy volunteers
No

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

Exclusion criteria

significant clinician identified comorbidities making them unable or inappropriate to participate in this study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026