N-WATCH: Nottingham Wheeze Assessment in Tidal Children

Brief summary (registry, in English)

Children with long-term lung diseases like asthma need better techniques for diagnosis and monitoring of their disease. With better monitoring, it is anticipated that children and their carers will be able to manage their disease better, and be able to spot a deterioration in their condition sooner, leading to earlier intervention, for example to prevent an asthma attack. However, current devices which could be used at home are either too costly, require machines that are impractically large, or require specific breathing maneuvers which are unpopular with patients, or which are difficult for younger children to perform. There is a need for better devices. The N-Tidal C is a CE Marked medical device which measures exhaled carbon dioxide levels accurately. Early work in its use in adult diseases such as Chronic Obstructive Pulmonary Disease indicates that the device can detect altered lung function associated with disease. This device has several attractive properties for children - it is small, easy to use, and does not require specific breathing maneuvers - just normal breathing. Based on data from a small feasibility study, the study investigators believe that this device will be useful in children. Young children can use it with minimal instruction. Parents and children have reported that it is easy to use. The investigators do not yet have sufficient feasibility information required to plan a larger study, such as deciding how many children the future study will need to recruit, or knowing how well the measurements made with the device agree with standard lung function tests. In this work, the investigators are conducting a feasibility study to determine the number of children needed for a larger trial and to explore how well the N-Tidal C device measurements compare with standard lung function tests. Data from this study will be used to plan future larger studies of the device in children with respiratory diseases.

What you commit to

• Study type: Observational
• Planned participants: 340
• From 15 Jul 2024 to the primary completion date, 31 Dec 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age in the registry: 5 years to 15 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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