NCT06292299 The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
| NCT ID | NCT06292299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NHS Greater Clyde and Glasgow |
| Condition | Sleep Disordered Breathing |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2024-03-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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 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 patient inappropriate to be included in study
Contact & Investigator
Ross J Langley, MBChB BSc PhD MRCPCH
PRINCIPAL INVESTIGATOR
NHS Greater Glasgow and Clyde
Frequently Asked Questions
Who can join the NCT06292299 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 16 Years, studying Sleep Disordered Breathing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06292299 currently recruiting?
Yes, NCT06292299 is actively recruiting participants. Contact the research team at ross.langley@ggc.scot.nhs.uk for enrollment information.
Where is the NCT06292299 trial being conducted?
This trial is being conducted at Glasgow, United Kingdom, Glasgow, United Kingdom.
Who is sponsoring the NCT06292299 clinical trial?
NCT06292299 is sponsored by NHS Greater Clyde and Glasgow. The principal investigator is Ross J Langley, MBChB BSc PhD MRCPCH at NHS Greater Glasgow and Clyde. The trial plans to enroll 225 participants.