Pulmonary FibrosisNCT05771740
Pulmonary Fibrosis Lung Sounds Study
An observational study of Pulmonary Fibrosis and Healthy, run by Royal Devon and Exeter NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis, Healthy
- What is being tested?
- Stemoscope (bluetooth sound amplifier)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Stemoscope (bluetooth sound amplifier)
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stemoscope (bluetooth sound amplifier)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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Fibrosis Patient | Participants under the clinical care of the interstitial lung disease team at the Royal Devon University Healthcare NHS Trust, UK Receives: Device: Stemoscope (bluetooth sound amplifier) | |
| Healthy Control | Healthy participants visiting the Royal Devon University Healthcare NHS Trust, UK Receives: Device: Stemoscope (bluetooth sound amplifier) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 8 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Gibbons, Principal investigator, Royal Devon University Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771740
- Sponsor's protocol ID
- 2304409
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available on an anonymised basis via Open Research Exeter data depository (https://ore.exeter.ac.uk/repository).
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05771740
- Acronym / sponsor ID
- 2304409
- Conditions
- Pulmonary Fibrosis, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Fibrosis Patient | – | Device: 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 | – | Device: Stemoscope (bluetooth sound amplifier)Healthy participants visiting the Royal Devon University Healthcare NHS Trust, UK |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- Able to understand what the study involves
- Able and willing to give informed consent
- 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)
- Age≥60 (to ensure that age of controls is similar to that of patients so that younger age does not bias results)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy Control, Pulmonary Fibrosis Patient |
Primary outcome
Number of clinical lung sound recordings stored from pulmonary fibrosis cases and controls
Time frame: 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.
Measure of ability of this system to classify participants as PF patients or healthy controls
Time frame: 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
Time frame: 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
1 secondary outcome
A correlation between clinical measures of pulmonary fibrosis severity and the audio waveform
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be available on an anonymised basis via Open Research Exeter data depository (https://ore.exeter.ac.uk/repository).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gibbons principal investigator
Royal Devon University Healthcare NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and Healthy, run by Royal Devon and Exeter NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Duckworth, PhD (07785386194, ad653@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical lung sound recordings stored from pulmonary fibrosis cases and controls (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.