An observational study in Sleep Disordered Breathing, Apnea of Prematurity and Respiratory Rate, sponsored by NHS Greater Clyde and Glasgow. Recruiting at 2 sites in United Kingdom. Open to participants aged 1 Minute to 16 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by NHS Greater Clyde and Glasgow · Observational
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.
Sleep diagnostics
The investigation of sleep disordered breathing (SDB) in children can be challenging given the requirement to apply sensors/bands that measure physiological changes as part of a cardiorespiratory sleep study (CR-poly). Children with sensory/behavioural issues, who have an increased risk of SDB, often find tolerability of standard diagnostic equipment difficult. Similarly, the usefulness is limited in low weight infants. Thus, there is a need to investigate novel devices which may provide sleep diagnostic information when a CR-poly may be inappropriate or challenging. A wearable respiratory rate (RR)/effort sensor can provide continuous remote monitoring of patients and may identify abnormal breathing patterns associated with SDB.
Central apnoea and abnormal breathing patterns in neonatal patients
Babies born prematurely can often have apnoea of prematurity requiring caffeine therapy. Similarly, term (or term corrected) infants can have immature breathing control which manifests as excessive central breathing pauses whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard CR-poly equipment. We aim to use the Pneumowave sensor alongside other diagnostic equipment to assess the feasibility of using this novel sensor to aid diagnosis in the post-natal period and pre-discharge from neonatal unit. Currently, newborn infants receive no standard respiratory monitoring following delivery. We aim to use the Pneumowave sensor as an indicator of altered respiratory patterns in this patient group.
Apnoeas in patients attending the epilepsy monitoring unit
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. We aim to use the Pneumowave sensor alongside other diagnostic equipment to assess the feasibility of using this novel sensor to detect ictal and post-ictal apnoea in children attending inpatient EEG video-telemetry monitoring. There are no clinical or commercially-available reliable sensors to detect epileptic apnoea. We aim to use the Pneumowave sensor as an indicator of altered respiratory patterns in this patient group and assess whether data can be reliably collected in the context of an epileptic seizure.
PneumoWave Ltd Device
PneumoWave Ltd is developing a small, chest-worn, ambulatory biosensor ("Pneumowave") to detect changes in a range of respiratory metrics. This physical monitor is linked wirelessly via Bluetooth to a central monitoring systems in the form of a mobile platform app (running on a smartphone or tablet). Real-time data analysis, event detection and alert response management algorithms will eventually be are located in the hub, mobile app - they are currently in the cloud depending on the device configuration.
The proposed technology, Pneumowave device, will be used in the diagnosis, treatment and monitoring of illness, and therefore must be regulated as a Class 2 Medical Device in accordance with the regulatory framework in each country of use. To achieve this, PneumoWave Ltd first intends to develop a device capable of detecting adverse respiratory events in the hospital setting where immediate attendance to alerts is available. Further technical development will be required prior to the submission for regulatory approval of a device that is suitable for use in the community where there may be a longer time before a response is activated.
This hospital study aims to compare the PneumoWave Ltd monitoring system with the current clinical standard for such monitoring in a range of hospital-based clinical services.
The studies will observe three distinct patient groups:
Group 1: Patients attending for an overnight CR-poly Group 2: Patients who are at risk of apnoea in the neonatal unit Group 3: Patients who are at risk of apnoea in the epilpsey monitoring unti
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 225 is above the median of 150 across 343 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →NHS Greater Clyde and Glasgow is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1 - CR-poly group
Group 2 - Apnoea group
Group 3- VT Group attending epilepsy monitoirng unit
Exclusion Criteria:
Group 1 - CR-poly group
Group 2 - Apnoea group
Group 3- VT Group attending epilepsy monitoirng unit
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any patient attending the Royal Hospital for Children, Glasgow sleep laboratory for overnight cardiorespiratory polysomnography for evaluation of sleep disordered breathing. Pneumowave device will collect data from patients alongside standard clinical monitoring.
Device: Pneumowave
Any patient currently in the Queen Elizabeth University Hospital campus neonatal unit at risk of central apnoea receiving standard care (this may include mechanically ventilated patients). Pneumowave device will collect data from patients alongside standard clinical monitoring.
Device: Pneumowave
Any patient attending the Royal Hospital for Children, Glasgow Epilepsy Monitoring Unit for inpatient video-telemetry at risk of apnoea during and following seizures
Device: Pneumowave
Pneumowave 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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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)
Time frame: 2 years
Not enrolling at this site.
Plan to share: Yes — IPD will be shared with other collaborators on the grant. No identifiable data will be shared.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: IPD will be available by December 2025
Access criteria: PneumoWave will be able to access IPD, no patient identifiable information will be shared with PneumoWave. IPD from this study will be included in a final report, presented at paediatric meetings and published in peer reviewed paediatric journals.
Data sharing details ↗ · www.researchdata.scot
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NHS Greater Clyde and Glasgow