The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study

NCT06292299 | Recruiting

• 2 other identifiers: INGN22RM471P10072600
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (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

  1\) Length of time device in situ on patient 2) Number of times device removed by patient / other 3) Ability of device to collect data while in situ

  2 years

Secondary Outcomes (4)

• 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

  2 years

• Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography

  2 years

• Collate waveform and motion artefact data in neonatal patients at risk of central apnoea

  2 years

• Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient

  2 years

Study Arms (3)

Patient attending for overnight cardiorespiratory polysomnography sleep study

Any patient attending the Royal Hospital for Children, Glasgow sleep laboratory for overnight cardiorespiratory polysomnography for evaluation of sleep disordered breathing. Pneumowave device will collect data from patients alongside standard clinical monitoring.

Device: Pneumowave

Patients in the neonatal unit, Royal Hospital for Children, Glasgow, at risk of central apnoea

Any patient currently in the Queen Elizabeth University Hospital campus neonatal unit at risk of central apnoea receiving standard care (this may include mechanically ventilated patients). Pneumowave device will collect data from patients alongside standard clinical monitoring.

Device: Pneumowave

Patients attending the epilepsy monitoirng unit for Video Telemetry

Any patient attending the Royal Hospital for Children, Glasgow Epilepsy Monitoring Unit for inpatient video-telemetry at risk of apnoea during and following seizures

Device: Pneumowave

Interventions

Pneumowave DEVICE

Pneumowave biosensor(s) will be be used to collect data from chest +/- abdominal movement and compared to standard clinical monitoring data

Patient attending for overnight cardiorespiratory polysomnography sleep study; Patients attending the epilepsy monitoirng unit for Video Telemetry; Patients in the neonatal unit, Royal Hospital for Children, Glasgow, at risk of central apnoea

Eligibility Criteria

• Age: 1 Minute - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Clyde and Glasgow: lead
• INNOVATEUK: collaborator

Study Sites (2)

Royal Hospital for Children, Glasgow

Glasgow, Glasgow City, G51 4TF, United Kingdom

RECRUITING

Royal Hospital for Children, Glasgow

Glasgow, Glasgow, G51 4TF, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (7)

• 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.

  PMID: 21896964 RESULT

• 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.

  PMID: 27384980 RESULT

• 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.

  PMID: 23733842 RESULT

• 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.

  PMID: 30795595 RESULT

• 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.

  PMID: 12892358 RESULT

• 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.

  PMID: 31304358 RESULT

• Vennard H, Buchan E, Miller J, Kelly S, Cowan C, Meredith O, Henderson B, Lowe DJ, Patel N, Zuberi S, Langley R. Respiratory monitoring and apnoea detection in paediatric and neonatal patients using a wearable accelerometer-based chest sensor: protocol for an observational diagnostic feasibility study. BMJ Open. 2025 Aug 31;15(8):e104363. doi: 10.1136/bmjopen-2025-104363.

  PMID: 40887117 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Apnea; Sudden Unexpected Death in Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Death, Sudden; Death; Pathologic Processes

Study Officials

• Ross J Langley, MBChB BSc PhD MRCPCH

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross J Langley, MBChB BSc PhD MRCPCH

CONTACT

01414516582; ross.langley@ggc.scot.nhs.uk

Hannah Vennard, MBChB BMSc

CONTACT

01414516582; hannah.vennard@ggc.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ross Langley

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 5, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD will be available by December 2025
• Access Criteria: PneumoWave will be able to access IPD, no patient identifiable information will be shared with PneumoWave. IPD from this study will be included in a final report, presented at paediatric meetings and published in peer reviewed paediatric journals.

Locations

GB (2)