Observational study on a new wearable device for diagnosing sleep breathing issues in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 patient inappropriate to be included in study

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.