The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasi… (NCT06292299) | Clinical Trial Compass
RecruitingNot Applicable
The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
United Kingdom225 participantsStarted 2024-03-01
Plain-language summary
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.
Who can participate
Age range
1 Minute – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Group 1 - CR-poly group
* 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
* 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 Criteria:
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
* Treating clinician deems patient inappropriate to be included in study
Group 3- VT Group attending epilepsy monitoirng unit
* Unable to provide consent and no next of kin to provide consent on participants behalf
* Treating clinician deems pat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an observational feasibility study — meaning researchers are testing whether the Pneumowave device can reliably collect breathing data, not testing a new treatment — what does that mean for my child's care, and would they still receive all their usual monitoring and treatment as normal?
2My child is being seen for sleep disordered breathing or is in the neonatal unit — does this study apply to both settings, and which one would my child be enrolled in given their specific situation?
3Because this study is only measuring whether it's possible to gather respiratory data with this device, rather than testing whether it improves outcomes, how might the information collected actually benefit my child or other children in the future?
4The trial mentions sudden unexpected death in epilepsy as one of the conditions involved — if my child has epilepsy, is this device being used to look at breathing patterns related to seizures, and what would happen if the device detected something concerning during the study?
5Are there any extra procedures, visits, or monitoring requirements on top of what my child is already scheduled for — such as the sleep lab polysomnography or neonatal unit stay — and how much additional time or disruption should we expect for our family?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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