None listed
Conditions
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.
Interventions
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
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.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
2 Years to 7 Years
Healthy volunteers
No
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
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
Outcome results
None listed