Clinical trial NCT06292299: The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Official title: The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disordered Breathing
Apnea of Prematurity
Respiratory Rate
Sudden Unexpected Death in Epilepsy
Keywords: Sleep Disordered Breathing
Neonatal Apnoea
Sleep Diagnostics
Wearable Device
Respiratory Rate
Respiratory Pattern
Epilepsy
Lead sponsor: NHS Greater Clyde and Glasgow
Sponsor class: OTHER
Collaborators: name: INNOVATEUK
First posted: 2024-03-05
Enrollment: 225
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

Group 1 - CR-poly group

* Patient undergoing overnight CR-poly
* Age birth to \&amp;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\&amp;#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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography
timeFrame: 2 years
measure: Collate waveform and motion artefact data in neonatal patients at risk of central apnoea
timeFrame: 2 years
measure: Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient
timeFrame: 2 years
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children, Glasgow
state: Glasgow City
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children, Glasgow
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Ross J Langley, MBChB BSc PhD MRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ono T, Takegawa H, Ageishi T, Takashina M, Numasaki H, Matsumoto M, Teshima T. Respiratory monitoring with an acceleration sensor. Phys Med Biol. 2011 Oct 7;56(19):6279-89. doi: 10.1088/0031-9155/56/19/008. Epub 2011 Sep 6.
citation: Williams GW 2nd, George CA, Harvey BC, Freeman JE. A Comparison of Measurements of Change in Respiratory Status in Spontaneously Breathing Volunteers by the ExSpiron Noninvasive Respiratory Volume Monitor Versus the Capnostream Capnometer. Anesth Analg. 2017 Jan;124(1):120-126. doi: 10.1213/ANE.0000000000001395.
citation: Voscopoulos C, Brayanov J, Ladd D, Lalli M, Panasyuk A, Freeman J. Special article: evaluation of a novel noninvasive respiration monitor providing continuous measurement of minute ventilation in ambulatory subjects in a variety of clinical scenarios. Anesth Analg. 2013 Jul;117(1):91-100. doi: 10.1213/ANE.0b013e3182918098. Epub 2013 Jun 3.
citation: Massaroni C, Nicolo A, Lo Presti D, Sacchetti M, Silvestri S, Schena E. Contact-Based Methods for Measuring Respiratory Rate. Sensors (Basel). 2019 Feb 21;19(4):908. doi: 10.3390/s19040908.
citation: Folke M, Cernerud L, Ekstrom M, Hok B. Critical review of non-invasive respiratory monitoring in medical care. Med Biol Eng Comput. 2003 Jul;41(4):377-83. doi: 10.1007/BF02348078.
citation: Chu M, Nguyen T, Pandey V, Zhou Y, Pham HN, Bar-Yoseph R, Radom-Aizik S, Jain R, Cooper DM, Khine M. Respiration rate and volume measurements using wearable strain sensors. NPJ Digit Med. 2019 Feb 13;2:8. doi: 10.1038/s41746-019-0083-3. eCollection 2019.