Pulmonary Fibrosis Lung Sounds Study

Not yet recruiting

• Conditions: Pulmonary Fibrosis; Healthy
• Interventions: Device: Stemoscope (bluetooth sound amplifier)

• Registration Number: NCT05771740
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-30
• Status Verified: 2023-03
• Study Start: 2023-03
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Fibrosis Patient	Stemoscope (bluetooth sound amplifier)	Participants under the clinical care of the interstitial lung disease team at the Royal Devon University Healthcare NHS Trust, UK
Healthy Control	Stemoscope (bluetooth sound amplifier)	Healthy participants visiting the Royal Devon University Healthcare NHS Trust, UK

Primary Outcome Measures

Name	Time	Method
Measure of ability of this system to classify participants as PF patients or healthy controls	8 months	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
Feedback from patients and study clinicians	8 months	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
Number of clinical lung sound recordings stored from pulmonary fibrosis cases and controls	6 months	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.

Secondary Outcome Measures

Name	Time	Method
A correlation between clinical measures of pulmonary fibrosis severity and the audio waveform	6 months	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.