Pulmonary Fibrosis Lung Sounds Study

Feasibility Study for Gathering Lung Sound Recordings From Pulmonary Fibrosis Patients and Healthy Controls and Classifying Disease Status Using a Combination of Digital Sound Device and Machine Learning

The goal of this observational study is to test whether it is possible to detect particular lung sounds that are unique to patients with the lung disease pulmonary fibrosis and whether any such sounds could be analysed using machine learning to make diagnosing disease easier.

Participants will have a sound detection device placed in different locations on the chest and audio sounds will be recorded for analysis.

Researchers will compare audio recordings from clinically diagnosed patients with recordings from healthy controls of a similar age to see whether the sounds are sufficiently different within that age group.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Pulmonary Fibrosis
• Intervention / Treatment: Device: Stemoscope (bluetooth sound amplifier)

Detailed Description

This is a study of chest audio recordings obtained using a sound enhancer, in this case a Bluetooth device, combined with intelligent computer-processing and analysis. It is being carried out amongst pulmonary fibrosis patients and healthy controls of a similar age, with the aim to improve diagnosis of pulmonary fibrosis and remote monitoring of disease progression.

Expert respiratory doctors gain important insights about the health of a patient's lungs by listening to the chest with a stethoscope. Currently, there are insufficient respiratory experts and specialist equipment to meet the patient demand, leading to delays in diagnosis and treatment and a shortage of specialist care following diagnosis.

In this study the investigators are aiming to make that specialist practice much more available by recording lung sounds and developing software to do the intelligent analysis. Initial tests with publicly available recordings of expertly diagnosed respiratory sounds have shown that different lung diseases can be detected with a very high degree of accuracy using new software. Here the investigators want to test that software with a cost-effective digital sound device in a clinical setting. The aim is for respiratory diseases to be diagnosed quickly and easily and also, in future, for patients to be offered the option to monitor how well they are after diagnosis in their own home.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Anna Duckworth, PhD; Phone Number: 07785386194; Email: ad653@exeter.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

50 Patients with a diagnosis of progressive pulmonary fibrosis attending routine interstitial lung disease clinic (age≥60) 50 Healthy controls of a similar age range (age≥60)

Description

Inclusion Criteria

• Able to understand what the study involves
• Able and willing to give informed consent

For patients:

• Age≥60 (PF affects adults, with the majority of age≥60)
• A diagnosis of progressive pulmonary fibrosis (to include all diagnosed interstitial lung disease (ILD) patients presenting at the ILD clinic)

For healthy controls:

• Age≥60 (to ensure that age of controls is similar to that of patients so that younger age does not bias results)
• No known lung disease

Exclusion Criteria

• Unable to understand what the study involves
• Unwilling or unable to give consent
• Age<60 (to ensure that age does not confound results and cases and controls are of similar age, since the majority of pulmonary fibrosis patients are of age≥60)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Fibrosis Patient; Participants under the clinical care of the interstitial lung disease team at the Royal Devon University Healthcare NHS Trust, UK	Device: Stemoscope (bluetooth sound amplifier); The bluetooth device will be placed in six locations on the front and six locations on the back of the chest and sound recordings stored for each location.
Healthy Control; Healthy participants visiting the Royal Devon University Healthcare NHS Trust, UK	Device: Stemoscope (bluetooth sound amplifier); The bluetooth device will be placed in six locations on the front and six locations on the back of the chest and sound recordings stored for each location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clinical lung sound recordings stored from pulmonary fibrosis cases and controls	A measure of the feasibility of gathering 12 lung sound files from each of 50 PF patients and 50 healthy volunteers in a similar age-group in the available timeframe.	6 months
Measure of ability of this system to classify participants as PF patients or healthy controls	A measure of the capability of the machine learning model combined with the cost-effective bluetooth stethoscope to classify study participants as PF patients or healthy controls from lung sound recordings alone in a clinical setting	8 months
Feedback from patients and study clinicians	Feedback from patients and study clinicians about the acceptability of digital sound monitoring for improving future diagnosis and monitoring of disease progression in pulmonary fibrosis	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A correlation between clinical measures of pulmonary fibrosis severity and the audio waveform	A demonstrable correlation between objective markers of pulmonary function tests (forced vital capacity percent of predicted (FVC%) or diffusing capacity in the lung for carbon monoxide percentage predicted (DLCO%)) or breathlessness symptoms (mMRC Dyspnoea score) and the waveform of the audio recording.	6 months

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Investigators: Principal Investigator: Michael Gibbons, Royal Devon University Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Fibrosis; Pulmonary Fibrosis; Respiratory Sounds
• Other Study ID Numbers: 2304409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available on an anonymised basis via Open Research Exeter data depository (https://ore.exeter.ac.uk/repository).
• IPD Sharing Time Frame: In accordance with MRC data sharing policy, the anonymous electronic data will be stored indefinitely and will be available for sharing for research purposes on request after 2 years from receipt of the full dataset.
• IPD Sharing Access Criteria: Available on request as above
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No