Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY, United Kingdom
NCT Number: NCT04504838
The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort and therefore has considerable benefits over current breathing tests which require significant patient effort.
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Notify Me7 year and older
All sexes
Observational
Portsmouth, Hampshire, PO6 3LY, United Kingdom
People with more severe asthma suffer from frequent asthma attacks that require regular hospital admissions. These attacks are difficult to predict and can devastate the lives of patients. A new tool is needed that can help to predict when an asthma attack is going to happen. This would help people recognise an attack earlier and allow treatment to be started sooner. This study will evaluate a new breathing monitor, to see whether it can detect asthma attacks. The study tests a new device, called 'N-Tidal C', which uses a method that has the potential to predict when attacks are about to happen. The investigators have found that people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients are having an attack of their disease. If patients could monitor their CO2, they may recognise when their asthma is getting worse, and take earlier action to avoid attacks getting out of hand and going to hospital.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From baseline until study completion, up to 12 months.
To collect Tidal Breathing Carbon Dioxide (TBCO2) breath records, twice daily per participant, which will be correlated to patient reported outcomes and clinical assessments.
Time frame: From baseline until study completion, up to 12 months.
Asthma Control Questionnaire (ACQ) (0= no impairment 6 = maximum impairment)
Time frame: From baseline until study completion, up to 12 months.
Asthma Quality of Life Questionnaire (AQLQ) 7 = not impaired at all - 1 = severely impaired
Time frame: From baseline until study completion, up to 12 months.
Visual Analogue Scale (VAS) (7=easy to use - 28=difficult to use)
Time frame: From baseline until study completion, up to 12 months.
Work Productivity and Activity Impairment Questionnaire (WPAI): Asthma (1=employed - 5= health affected productivity while working)
TidalSense
Industry
A Longitudinal, Observational Study to Explore the Tidal Breathing Carbon Dioxide (TBCO2) Waveform, Measured Using the N-Tidal C Device, in Asthma
Acronym: ABRS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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