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.
Patient undergoing overnight CR-poly
Age birth to >=16 years
Are willing and able to give informed assent/consent or have available next of Kin to provide informed consent on the participant's behalf
Able (in the Investigators opinion) to comply with all study requirements
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
No next of kin to provide consent on participants behalf
Treating clinician deems patient inappropriate to be included in study
The target number of participants in this study is 225. 75 patients who fit group 1 characteristics, 75 patients who fit group 2 characteristics and 75 patients who fit group 3 characteristics.
Cohort
Prospective
Pneumowave
DevicePneumowave biosensor(s) will be be used to collect data from chest +/- abdominal movement and compared to standard clinical monitoring data
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
1\) Length of time device in situ on patient 2) Number of times device removed by patient / other 3) Ability of device to collect data while in situ
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
(1) Observation of waveform data from Pneumowave device and compare to: normal care vital signs and continuous monitoring vital signs extracted from patient monitors. (2) Compare Pneumowave respiratory wave patterns to clinical events: normal respiratory patterns and clinical deterioration
Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography
Compare respiratory waveform patterns and motion artefact data to: banded sleep diagnostic information
Collate waveform and motion artefact data in neonatal patients at risk of central apnoea
(1) Observation of waveform data from Pneumowave device and compare to: normal care vital signs, continuous monitoring vital signs extracted from patient monitors (2) Compare Pneumowave respiratory wave patterns to clinical events: normal respiratory patterns, clinical deterioration ,Interventions in neonatal unit
Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient
Interview of the stakeholders on the useability of the device: Clinician, Nurse, Patient (if able to)
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NHS Greater Clyde and Glasgow
Lead sponsor
INNOVATEUK
Collaborator
