Central apnoea monitor study
Research type
Research Study
Full title
Feasibility study to evaluate a new wearable wireless device for monitoring central apnoeas in infants and children
IRAS ID
325626
Contact name
Heather Elphick
Contact email
Sponsor organisation
Sheffield Hallam University
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Central sleep apnoea is intermittent cessation of airflow to the lungs during sleep due to failure of respiratory control from the central nervous system. The condition affects around 1% babies under the age of 1 year and is one of the causes of sudden infant death syndrome. There is a requirement for long-term monitoring within the home of children who are subject to significant central apnoea.
Current devices involve a sensor attached to the child’s abdomen with a wire connecting the sensor to a device that sits in the cot or by the bedside. An alarm is triggered to alert the carer if no movement is detected by the sensor during a set time limit. The carer attends the child to provide assistance as needed. There are concerns around the accuracy, cost and safety of these devices as episodes of entanglement which could involve the wire around the child’s neck have been reported. A new device needs to be accurate and cost-effective and should ideally be wireless to avoid the risk of strangulation.
The team at Sheffield Hallam University, the University of Sheffield and Sheffield Children’s Hospital have developed a device that monitors for apnoeas using an elasticated band that fits around the child’s abdomen. The alarm is integrated within the band so that no wires are involved. The device has already been tested in adults and accurately detects apnoeas.
We propose an initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Children’s Hospital. The central apnoea monitor will be placed around the child’s abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0086
Date of REC Opinion
24 Apr 2023
REC opinion
Favourable Opinion