Pulmonary Fibrosis Lung Sounds Study

NCT ID: NCT05771740

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2023-12-31

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.

Conditions

Pulmonary Fibrosis; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pulmonary Fibrosis Patient

Participants under the clinical care of the interstitial lung disease team at the Royal Devon University Healthcare NHS Trust, UK

Stemoscope (bluetooth sound amplifier)

Intervention Type: DEVICE

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

Stemoscope (bluetooth sound amplifier)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Gibbons

Role: PRINCIPAL_INVESTIGATOR

Royal Devon University Healthcare NHS Trust

Central Contacts

Anna Duckworth, PhD

Role: CONTACT

ad653@exeter.ac.uk

07785386194

Other Identifiers

2304409

Identifier Type: -

Identifier Source: org_study_id