Sleep Disordered BreathingPARSNCT06292299
The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
An observational study of Sleep Disordered Breathing and Apnea of Prematurity, run by NHS Greater Clyde and Glasgow at 2 sites in United Kingdom.
Trial 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". Read more about this study
- Who is it for?
- Ages 1 minute to 16 years
- Conditions the study is for
- Sleep Disordered Breathing, Apnea of Prematurity, Respiratory Rate
- What is being tested?
- Pneumowave
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2024to Dec 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 1 recruiting
- Recruiting
Royal Hospital for Children, Glasgow
Glasgow, Glasgow City, G51 4TF
Ross J Langley, MBChB BSc PhD MRCPCH, 0141 451 6582, ross.langley@ggc.scot.nhs.uk
Hannah Vennard, MBChB BMSc, 0141 451 6582, hannah.vennard@ggc.scot.nhs.uk
- Active, not recruiting
Royal Hospital for Children, Glasgow
Glasgow, Glasgow, G51 4TF
About this study
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.
Read more
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.
Read the 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
- Conditions
- Sleep Disordered Breathing, Apnea of Prematurity, Respiratory Rate, Sudden Unexpected Death in Epilepsy
- Being tested
- Pneumowave
- Keywords
- Sleep Disordered Breathing, Neonatal Apnoea, Sleep Diagnostics, Wearable Device, Respiratory Rate, Respiratory Pattern, Epilepsy
- Medical subject headings
- Sleep Apnea Syndromes, Apnea, Sudden Unexpected Death in Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumowaveDevice
Pneumowave biosensor(s) will be be used to collect data from chest +/- abdominal movement and compared to standard clinical monitoring data
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Device: Pneumowave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 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
(1) Observation of waveform data from Pneumowave device and compare to: normal care vital signs and continuous monitoring vital signs extracted from patient monitors. (2) Compare Pneumowave respiratory wave patterns to clinical events: normal respiratory patterns and clinical deterioration
Measured: 2 years
Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography
Compare respiratory waveform patterns and motion artefact data to: banded sleep diagnostic information
Measured: 2 years
Collate waveform and motion artefact data in neonatal patients at risk of central apnoea
(1) Observation of waveform data from Pneumowave device and compare to: normal care vital signs, continuous monitoring vital signs extracted from patient monitors (2) Compare Pneumowave respiratory wave patterns to clinical events: normal respiratory patterns, clinical deterioration ,Interventions in neonatal unit
Measured: 2 years
Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient
Interview of the stakeholders on the useability of the device: Clinician, Nurse, Patient (if able to)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- NHS Greater Clyde and Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- INNOVATEUK
- Responsible party
- Principal investigator, Ross Langley, NHS Greater Clyde and Glasgow
- Investigators
- Ross J Langley, MBChB BSc PhD MRCPCH, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292299
- Sponsor's protocol ID
- INGN22RM471P
- Other IDs
- 10072600
- Acronym
- PARS
- Status last verified
- May 2025
- First submitted
- 26 Feb 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other collaborators on the grant. No identifiable data will be shared.
Publications
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.
PubMed 21896964Williams 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.
PubMed 27384980Voscopoulos 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.
PubMed 23733842Massaroni 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.
PubMed 30795595Folke 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.
PubMed 12892358Chu 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.
PubMed 31304358Vennard 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.
PubMed 40887117
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
- ClinicalTrials.gov ID
- NCT06292299
- Acronym / sponsor ID
- PARS / INGN22RM471P
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- NHS Greater Clyde and GlasgowUniversity, hospital or other
- Collaborators
- INNOVATEUK
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient attending for overnight cardiorespiratory polysomnography sleep study | – | Device: PneumowaveAny 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. |
| Patients in the neonatal unit, Royal Hospital for Children, Glasgow, at risk of central apnoea | – | Device: PneumowaveAny 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. |
| Patients attending the epilepsy monitoirng unit for Video Telemetry | – | Device: PneumowaveAny patient attending the Royal Hospital for Children, Glasgow Epilepsy Monitoring Unit for inpatient video-telemetry at risk of apnoea during and following seizures |
Who may qualify
- Ages
- 1 minute to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PneumowavePneumowave biosensor(s) will be be used to collect data from chest +/- abdominal movement and compared to standard clinical monitoring data | Device | 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 |
Primary outcome
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
Time frame: 2 years
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
4 secondary outcomes
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
Time frame: 2 years
Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography
Time frame: 2 years
Collate waveform and motion artefact data in neonatal patients at risk of central apnoea
Time frame: 2 years
Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 21896964Ono 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.
- Results publication: PubMed 27384980Williams 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.
- Results publication: PubMed 23733842Voscopoulos 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.
- Results publication: PubMed 30795595Massaroni 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.
- Results publication: PubMed 12892358Folke 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.
- Results publication: PubMed 31304358Chu 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.
- Derived from this study: PubMed 40887117Vennard 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.
- Individual participant dataSharing planned: Yes. IPD will be shared with other collaborators on the grant. No identifiable data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ross J Langley, MBChB BSc PhD MRCPCH principal investigator
NHS Greater Glasgow and Clyde
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing and Apnea of Prematurity, run by NHS Greater Clyde and Glasgow at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ross J Langley, MBChB BSc PhD MRCPCH (01414516582, ross.langley@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292299, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.