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Pulmonary Fibrosis Lung Sounds Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05771740
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Royal Devon and Exeter NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Gibbons
Principal Investigator Affiliation	Royal Devon University Healthcare NHS Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis, Healthy

Additional Details

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.

Arms & Interventions

Arms

: Pulmonary Fibrosis Patient

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

: Healthy Control

Healthy participants visiting the Royal Devon University Healthcare NHS Trust, UK

Interventions

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.