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Audio Technology To Detect Lung Cancer Earlier

Conditions
Lung Neoplasms
Cough
Interventions
Diagnostic Test: Leicester Cough Monitor (LCM)
Registration Number
NCT03566862
Lead Sponsor
NHS Greater Glasgow and Clyde
Brief Summary

A cross-sectional study of prospectively collected cough audio recordings using spectral analysis.

Detailed Description

In the UK lung cancer is the leading cause of cancer death, also, UK survival rates are poorer compared to other European countries. Lung cancer is plagued by late presentation; 70% present with advanced incurable disease and a third die within 90 days of diagnosis. As such, there is a clear and urgent need to achieve earlier diagnosis of lung cancer. Symptomatic presentation is the most common route to lung cancer diagnosis and symptoms may be present for many months before diagnosis, even in early stage disease. The most common (68%) presenting symptom is cough. Unfortunately cough is also common with other illnesses. Furthermore, a high proportion of those at high-risk of lung cancer have pre-existing cough or respiratory disease (e.g. ex- or current- smokers, patients with chronic obstructive pulmonary disease (COPD)). Cough sounds are known to vary according to underlying lung pathology and could therefore have diagnostic value. Potentially, there may be unique cough and/or respiratory sounds or patterns associated with lung cancer that are not detectable by the human audio spectrum. Identification of a tool that accurately discriminates lung cancer cough could be pivotal.

This is a prospective cross-sectional study that will involve subjective analysis of spectrograms of cough recorded from individuals with "normal" lungs, individuals at high-risk for lung cancer (COPD and other chronic lung diseases) and individuals with lung cancer. 24 hour ambulatory audio recordings will be prospectively collected from patients attending respiratory medicine clinics at Queen Elizabeth University Hospital (QEUH), Glasgow. Participants will be given a free-field lapel microphone and mp3 recorder for 24h. The Leicester Cough Monitor (LCM) will be used to extract the cough sounds from the 24h recordings. The LCM is an automated cough detection system that was developed by Dr Surinder Birring (Kings College Hospital). It uses an algorithm to automatically identify cough sounds from audio recordings, which is then able to provide data on cough frequency. As part of this process, the LCM splices out 1 second sound clips for all parts of the audio recordings that are identified as being (i) a cough sound or (ii) a non-cough sound.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Aged 50 years and above and who are either:
  • "Normal Smokers" - individuals who have presented with cough but who appear to have 'healthy' lungs (i.e. COPD, other chronic lung disease and lung cancer have been excluded after clinical assessment);
  • "COPD" - individuals with a confirmed diagnosis of COPD according to established criteria;
  • "Other (non-COPD) chronic lung disease" - individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma);
  • "Lung cancer" - individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough
Exclusion Criteria
  • Participants with an active or recent lung infection, as defined by either the production of purulent sputum associated with systemic symptoms or fever, and/or the receipt of antibiotics for lung infection or acute exacerbation over the 2 weeks preceding the date of consent
  • Participants who are unable to provide informed consent
  • Participants who are receiving/have previously received radiotherapy to the lungs
  • Participants who are currently receiving chemotherapy

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Lung cancerLeicester Cough Monitor (LCM)Individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough.
Normal smokersLeicester Cough Monitor (LCM)Individuals who have presented with cough but who appear to have 'healthy' lungs (i.e. COPD, other chronic lung disease and lung cancer have been excluded after clinical assessment).
COPDLeicester Cough Monitor (LCM)Individuals with a confirmed diagnosis of COPD according to established criteria.
Other (non-COPD) chronic lung diseaseLeicester Cough Monitor (LCM)Individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma).
Primary Outcome Measures
NameTimeMethod
Spectral centroid (Hz) measurement12 months

Spectral centroid (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Secondary Outcome Measures
NameTimeMethod
Spectral bandwith (Hz) measurement12 months

Spectral bandwith (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral crest factor (Hz) measurement12 months

Spectral crest factor (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral flatness (adimensional) measurement12 months

Spectral flatness (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral flux (Watts²) measurement12 months

Spectral flux (Watts²) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral roll-off (Hz) measurement12 months

Spectral roll-off (Hz) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Ratio f50 vs f90 (adimensional) measurement12 months

Ratio f50 vs f90 (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral peak entropy (adimensional measurement)12 months

Spectral peak entropy (adimensional measurement) of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral Renyi entropy (adimensional) measurement12 months

Spectral Renyi entropy (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral kurtosis (adimensional) measurement12 months

Spectral kurtosis (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral skewness (adimensional) measurement12 months

Spectral skewness (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Spectral entropy (adimensional) measurement12 months

Spectral entropy (adimensional) measurement of cough sounds to ascertain any similarities or differences in spectral characteristics between samples

Trial Locations

Locations (1)

Queen Elizabeth University Hospital Glasgow

🇬🇧

Glasgow, United Kingdom

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