N-Tidal study underway on breathing difficulties in young children

A new pilot study is underway in partnership with the University of Nottingham and Nottingham University Hospitals NHS Trust to investigate the use of a technology for diagnosing and monitoring respiratory conditions like asthma in children.

N-Tidal, a handheld respiratory device developed by TidalSense, aims to address a critical challenge in paediatric respiratory care by making it easier and more accessible to diagnose and monitor breathing difficulties in young children.

The study, which is funded by Small Business Research Initiative (SBRI) Healthcare, will investigate the use of N-Tidal in children under five years old with asthma and viral wheeze. It will involve 75 children in Nottingham with and without breathing difficulties. It will explore whether this novel technology can detect changes in the lungs associated with airway obstruction, a key feature of asthma and viral wheeze. Researchers will also explore its potential impact on healthcare delivery and sustainability, focusing on improvements in clinical pathways, accessibility, and cost-effectiveness.

Paediatric asthma and viral wheeze are leading causes of hospital visits and consultations, with asthma affecting a million children in the UK. Asthma is a chronic condition with wheezing triggered by various factors beyond just colds, while viral wheeze is temporary, linked to a specific infection, and resolves between episodes. Diagnosing both conditions in young children requires cooperation and effort from the child, typically involving spirometry which requires challenging manoeuvres involving forced exhalation.

Previous studies have shown that this method is considered difficult to perform, especially in preschool age children because they are less able to perform the breathing manoeuvres required than older children and adults. Clearly, for young patients and their families, spirometry can be a stressful and uncomfortable experience. If used incorrectly, they frequently lead to delayed diagnoses due to difficulties obtaining accurate data, and unnecessary healthcare costs associated with prolonged hospital stays and additional treatments.

N-Tidal on the other hand uses capnography, a widely used technique in acute and critical care, to measure CO2 levels in the breath during normal breathing in and out through the mouth. Unlike spirometry, forced breathing manoeuvres are not required to use N-Tidal.

The study will help determine whether the CO2 data collected using the N-Tidal device can be used to measure whether there is airway obstruction in the lungs of children with asthma and viral wheeze and how severe it is. This could then lead to the validation of N-Tidal as a novel diagnostic test for asthma in children or a better way of monitoring these conditions in a larger study. This would further evaluate the technology’s potential to revolutionise how breathing difficulties in young children are diagnosed and managed.

Dr. Andrew Prayle, clinical associate professor in paediatric respiratory medicine at the University of Nottingham and lead investigator of the pilot study, said: “We are extremely excited to be a key partner in this project. Asthma affects one in 10 children, and all clinicians would agree that we need better tools for diagnosing and monitoring asthma in childhood.”

Dr. Ameera Patel, CEO of TidalSense, added: “This new pilot study is a hugely exciting direction for TidalSense. Young children with suspected asthma are a big underserved population. Current diagnostic methods, such as spirometry, are very challenging to use in paediatric populations, hindering accurate and timely diagnosis. As it only requires relaxed breathing, making it significantly easier to administer, N-Tidal could bridge this gap, leading to improved diagnosis, earlier intervention and, ultimately, better outcomes for children with breathing difficulties. This pilot study is an important step in realising this potential and addressing a long-standing need in paediatric respiratory care.”

N-Tidal is already being tested by adults across the UK. In August last year, TidalSense announced the device will assess use of the device in Oxford who have possible and confirmed COPD. In November, it announced it received new funding to test 1,200 people in Hull who identified as having suspected COPD. The technology has also been used in numerous clinical studies; most recently, in those with high model confidence, the test has been shown to have a positive predictive value of 93% in COPD.