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 & 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.
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
- A subgroup of these patients will take the Pneumowave device home for extended
home-based sleep studies for up to 7 nights.
Group 2: Patients who are at risk of apnoea in the neonatal unit