NCT03566862

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

May 15, 2018

Last Update Submit

June 21, 2018

Conditions

Lung NeoplasmsCough

Outcome Measures

Primary Outcomes (1)

  • Spectral centroid (Hz) measurement

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

    12 months

Secondary Outcomes (11)

  • Spectral bandwith (Hz) measurement

    12 months

  • Spectral crest factor (Hz) measurement

    12 months

  • Spectral flatness (adimensional) measurement

    12 months

  • Spectral flux (Watts²) measurement

    12 months

  • Spectral roll-off (Hz) measurement

    12 months

  • +6 more secondary outcomes

Study Arms (4)

Lung cancer

Individuals with confirmed diagnosis of lung cancer including disease in the lungs and an active cough.

Diagnostic Test: Leicester Cough Monitor (LCM)

COPD

Individuals with a confirmed diagnosis of COPD according to established criteria.

Diagnostic Test: Leicester Cough Monitor (LCM)

Other (non-COPD) chronic lung disease

Individuals with a confirmed diagnosis of non-COPD chronic lung disease (e.g. pulmonary fibrosis, asthma).

Diagnostic Test: Leicester Cough Monitor (LCM)

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).

Diagnostic Test: Leicester Cough Monitor (LCM)

Interventions

Leicester Cough Monitor (LCM)DIAGNOSTIC_TEST

The Leicester Monitoring Cough (LCM) kit includes a digital flash voice recorder (Sony ICD-PX333), aA clip-on lapel microphone (Philips LFH9173) and a small carry/travel waist bag.

COPDLung cancerNormal smokersOther (non-COPD) chronic lung disease

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants for all 4 cohorts will be identified by the CI and associated research team by screening patients who attend respiratory clinics at QEUH with suspected lung cancer (for the "Normal Smokers" and Lung Cancer cohorts) and other established respiratory diseases (for the COPD and Other (non-COPD) chronic lung disease cohorts). Individuals will be recruited by the QEUH research nurse or CI when they attend the relevant outpatient clinics.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth University Hospital Glasgow

Glasgow, G51 4TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCough

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin G Blyth, MD

    NHSGG&C

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne McGarry

CONTACT

01412321818Joanne.McGarry@ggc.scot.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 25, 2018

Study Start

May 16, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)