Tests a wearable breathing sensor in babies and children with breathing or epilepsy concerns
Tests a small wearable breathing sensor in infants and children with sleep or breathing problems.
Plain-language title generated from the registry record
Registry title: The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Key facts
- Where
- Glasgow, United KingdomSee the site
Where in United Kingdom
- Royal Hospital for Children GlasgowGlasgow, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NHS Greater Clyde and Glasgow
- Trial code
- NCT06292299
- Record updated
- 14 April 2026
- Original description
Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomesRead full original descriptionShow less
The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes
Infants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes.
Children with epilepsy are at risk of epileptic apnoea during a seizure (ictal) or post-ictal apnoea following an epileptic seizure. Epileptic and post-ictal apnoea have been implicated as causes of sudden unexpected death in epilepsy (SUDEP). Epilepsy affects approx. 50 million people worldwide. The risk of SUDEP varies in different underlying causes of epilepsy but is estimated to be the cause of 1.2 deaths for every 1,000 children with epilepsy each year.
This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients and children with epilepsy at risk of SUDEP.
Inclusion: Group 1 - CR-poly group; Patient undergoing overnight CR-poly; Age birth to \&gt;=16 years; Are willing and able to give informed assent/consent or have available next of Kin to provide informed consent on the participant\&#39;s behalf; Able (in the Investigators opinion) to comply with all study requirements; Can speak and read English; Group 2 - Apnoea group; Inpatient in neonatal unit; Age birth (from 30 weeks gestational age) to term corrected; Parents willing and able to give informed consent; Able (in the Investigators opinion) to comply with all study requirements; Can speak and read English; Group 3- VT Group attending epilepsy monitoirng unit; Inpatient receiving video-telemetry epilepsy monitoring unit; Age birth to <16 years; Parents willing and able to give informed consent; Able (in the Investigators opinion) and willing to comply with all study requirements; Can speak and read English.
Exclusion: Treating clinician deems patient inappropriate to be included in study; Group 3- VT Group attending epilepsy monitoirng unit; Group 1 - CR-poly group; Unable to provide consent and no next of kin to provide consent on participants behalf; Treating clinician deems patient inappropriate to be included in study; Group 2 - Apnoea group; No next of kin to provide consent on participants behalf; Unable to provide consent and no next of kin to provide consent on participants behalf; Treating clinician deems patient inappropriate to be included in study.