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| Name | Class |
|---|---|
| Innovate UK | OTHER_GOV |
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This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.
When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or "waveform". This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.
This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma | 20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines | ||
| Chronic heart failure | 10 Participants with a diagnosis of chronic heart failure | ||
| Breathing Pattern Disorder | 10 Participants with a diagnosis of Breathing Pattern Disorder | ||
| Pneumonia | 10 participants with a radiologically confirmed diagnosis of pneumonia | ||
| Motor Neurone Disease | 10 participants with a diagnosis of motor neurone disease with known hypercapnic failure. | ||
| Healthy | 10 Participants who have no known lung, cardiac or neuromuscular condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Tidal Breathing carbon dioxide waveform over time | Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months. | Change measures - baseline to 6 months |
| Disease Control in asthma patients |
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Inclusion Criteria:
Asthma Cohort:
Breathing Pattern Disorder Cohort
Chronic heart failure Cohort:
A confirmed clinical diagnosis of chronic heart failure with both of the following:
Admitted with an acute decompensation of their heart failure to hospital within the last 6 months
Motor Neurone Disease Cohort:
Pneumonia Cohort:
Healthy Cohort:
Exclusion Criteria:
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The healthy Cohort will be made up of healthy volunteers. The Disease Cohorts will be selected from hospital outpatient clinic lists and inpatient wards.
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| Name | Affiliation | Role |
|---|---|---|
| Anoop J Chauhan, PhD | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals NHS Trust | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42205504 | Derived | Neville DM, Lim RH, Hawke E, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Begum S, De Vos R, Kalra P, Quint M, Adeniji K, Brown TP, Patel AX, Chauhan AJ. Breath-by-breath: unmasking cardio-respiratory conditions through capnography waveforms - the general breathing record study. Eur Clin Respir J. 2026 May 25;13(1):2661529. doi: 10.1080/20018525.2026.2661529. eCollection 2026. | |
| 37268935 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006333 | Heart Failure |
| D011014 | Pneumonia |
| D016472 | Motor Neuron Disease |
| D064706 | Vocal Cord Dysfunction |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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The Asthma Control Questionnaire Score for the Asthma patients
| 12 months |
| Disease Improvement in Breathing Pattern Disorder patients | The Nijmegen Questionnaire Score | 12 months |
| Disease severity in the pneumonia patients | The CURB-65 Score | 2 days |
| Disease severity in heart failure patients | The Trans Thoracic Echocardiogram (TTE) result | 12 months |
| Hypercapnia in the motor neurone disease patients | The level of partial pressure carbon dioxide (pCO2) | 12 months |
| Usability of the N-Tidal C device | Measured by how frequently the patients remember to use the N-Tidal C device over 6 months | Change measures - baseline to 6 months |
| Acceptability of the N-Tidal C device | Measured by a questionnaire of the participants experience of the device at the end of the study | 12 months |
| Derived |
| Talker L, Neville D, Wiffen L, Selim AB, Haines M, Carter JC, Broomfield H, Lim RH, Lambert G; BRS Study Team; Weiss ST, Hayward G, Brown T, Chauhan A, Patel AX. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer. Respir Res. 2023 Jun 2;24(1):150. doi: 10.1186/s12931-023-02460-z. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D007818 | Laryngeal Diseases |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |