protocolSection identificationModule nctId: NCT06292299, orgStudyIdInfo id: INGN22RM471P, secondaryIdInfos id: 10072600, type: OTHER_GRANT, domain: PneumoWave Ltd & Innovate UK, briefTitle: The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study, acronym: PARS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: NHS Greater Clyde and Glasgow, class: OTHER, collaborators name: INNOVATEUK, descriptionModule briefSummary: 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 outcomesInfants 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.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., conditionsModule conditions: Sleep Disordered Breathing, conditions: Apnea of Prematurity, conditions: Respiratory Rate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Pneumowave, outcomesModule primaryOutcomes measure: Assess the feasibility of collecting respiratory waveform data using Pneumowave device in patients who have (1) attended the sleep laboratory for CR- polysomnography and (2) are inpatient in neonatal unit, secondaryOutcomes measure: Collate respiratory data in patients who have attended the sleep laboratory for CR- poly or inpatient in neonatal unit. Respiratory data will observe: (1) Normal respiratory effort (2) Response to treatments, secondaryOutcomes measure: Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography, secondaryOutcomes measure: Collate waveform and motion artefact data in neonatal patients at risk of central apnoea, secondaryOutcomes measure: Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient, eligibilityModule sex: ALL, minimumAge: 1 Minute, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Royal Hospital for Children, Glasgow, city: Glasgow, state: Glasgow City, zip: G51 4TF, country: United Kingdom, contacts name: Ross J Langley, MBChB BSc PhD MRCPCH, role: CONTACT, phone: 0141 451 6582, email: ross.langley@ggc.scot.nhs.uk, contacts name: Hannah Vennard, MBChB BMSc, role: CONTACT, phone: 0141 451 6582, email: hannah.vennard@ggc.scot.nhs.uk, geoPoint lat: 55.86515, lon: -4.25763, locations facility: Royal Hospital for Children, Glasgow, city: Glasgow, zip: G51 4TF, country: United Kingdom, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False