Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2017-08-09
2018-07-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asthma
20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines
No interventions assigned to this group
Chronic heart failure
10 Participants with a diagnosis of chronic heart failure
No interventions assigned to this group
Breathing Pattern Disorder
10 Participants with a diagnosis of Breathing Pattern Disorder
No interventions assigned to this group
Pneumonia
10 participants with a radiologically confirmed diagnosis of pneumonia
No interventions assigned to this group
Motor Neurone Disease
10 participants with a diagnosis of motor neurone disease with known hypercapnic failure.
No interventions assigned to this group
Healthy
10 Participants who have no known lung, cardiac or neuromuscular condition.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* A confirmed clinical diagnosis of asthma for ≥ 6months
* Moderate to severe asthma defined as British Thoracic Society stages 3-5
* 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.
* Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).
Breathing Pattern Disorder Cohort
* A Clinical diagnosis of a Breathing Pattern Disorder (BPD)
Chronic heart failure Cohort:
* A confirmed clinical diagnosis of chronic heart failure with both of the following:
1. A Left Ventricular Ejection Fraction \<40% on most recent imaging within the last 12 months.
2. New York Heart Association Class 2-4
* Admitted with an acute decompensation of their heart failure to hospital within the last 6 months
Motor Neurone Disease Cohort:
* A confirmed clinical diagnosis of Motor Neurone Disease
* Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia.
* Established on Home Non-Invasive Ventilation.
Pneumonia Cohort:
* A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.
Healthy Cohort:
* No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.
Exclusion Criteria
* In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.
16 Years
ALL
Yes
Sponsors
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Innovate UK
OTHER_GOV
TidalSense
INDUSTRY
Responsible Party
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Principal Investigators
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Anoop J Chauhan, PhD
Role: PRINCIPAL_INVESTIGATOR
Portsmouth Hospitals NHS Trust
Locations
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Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom
Countries
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References
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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.
Other Identifiers
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G002-17_GBRS
Identifier Type: -
Identifier Source: org_study_id
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