Observational study on a new wearable device for diagnosing sleep breathing issues in children
The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
This study is testing a new wearable device to see if it can help doctors better diagnose breathing problems during sleep in children, especially those who find traditional tests hard to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 1 Minute to 16 Years |
| Sex | All |
| Sponsor | NHS Greater Clyde and Glasgow Academic / other |
| Locations | 2 sites (Glasgow, Glasgow City and 1 other locations) |
| Trial ID | NCT06292299 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using a novel wearable device, the Pneumowave sensor, to monitor respiratory patterns in children at risk of sleep disordered breathing (SDB). It aims to address the challenges of traditional diagnostic equipment, which can be difficult for infants and children with sensory or behavioral issues. By providing continuous remote monitoring, the study seeks to improve the diagnosis of conditions like apnea of prematurity and abnormal breathing patterns in neonates. The research will involve various groups of pediatric patients, including those undergoing cardiorespiratory polygraphy and those in neonatal units.
Who should consider this trial
Good fit: Ideal candidates include infants and children from birth to 16 years who are at risk for sleep disordered breathing or are undergoing monitoring for related conditions.
Not a fit: Patients who do not have sleep disordered breathing or are not within the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic capabilities for sleep disordered breathing in vulnerable pediatric populations.
How similar studies have performed: While there have been studies on wearable devices for monitoring respiratory patterns, this specific approach targeting pediatric populations with SDB is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glasgow, Glasgow City and 1 other locations
- Royal Hospital for Children, Glasgow — Glasgow, Glasgow City, United Kingdom (Recruiting)
- Royal Hospital for Children, Glasgow — Glasgow, Glasgow, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Ross J Langley, MBChB BSc PhD MRCPCH — NHS Greater Glasgow and Clyde
- Study coordinator: Ross J Langley, MBChB BSc PhD MRCPCH
- Email: ross.langley@ggc.scot.nhs.uk
- Phone: 01414516582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.