BronchomalaciaNCT03043898
Mapping Sound Propagation Through the Human Lung for Better Diagnosis
An observational study of Bronchomalacia and Asthma, run by Maximilian Nussbaumer at 1 site in United Kingdom.
Trial summary
This study investigates the propagation of sound from a source in the chest to the chest wall. The methodology of the study will be to place a sound source at a known location in the chest and measure the acoustic response on the posterior chest wall with an acoustic sensor array. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchomalacia, Asthma, Lung Neoplasms
- What is being tested?
- Lung sound transmission measurement and Lung sound recording
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2018to 23 Apr 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Part A(i) 50 healthy volunteers, taken from the general population. Part A(ii) 100 patients, taken from the population of patients at Addenbrooke's Hospital, Cambridge, UK with clear evidence of wheezing and/or crackles due to respiratory disease. We will aim to recruit approximately 50 patients with wheezing and 50 patients with crackles. Part B(i) 25 patients, taken from the population of patients on the bronchoscopy list at Addenbrooke's Hospital, Cambridge, UK. Part B(ii) 25 patients, taken from the population of patients on the bronchoscopy list at Addenbrooke's Hospital, Cambridge, UK
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male of Female, aged 18 years or above.
- Part A(i) Healthy volunteer with no history of smoking, recreational drug use or respiratory disease.
- Part A(ii) Patient admitted to Addenbrooke's with a pulmonary disease resulting in crackles and/or wheezes (as diagnosed by a qualified medical practitioner).
- Part B Patient admitted to Addenbrooke's hospital for a bronchoscopy procedure.
- Part B Appropriate recent imaging available: chest CT within 3 months.
- Part B(i) Lung structure deemed 'normal' by pulmonary physician based on CT scan and medical history.
- Part B(i) Lung structure deemed 'abnormal' by pulmonary physician based on CT scan and medical history.
Who cannot join
- Informed consent is not given.
- Subject is under 18 years old.
- WHO performance status >2.
- Subject is pregnant.
- Subject is unable to understand English.
- Part A(i) History of smoking, recreational drug use or respiratory disease.
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- Part A(ii) Condition judged to have no effect on breathing sounds. Patient with crackle or wheeze when quota for crackle or wheeze patients respectively is fulfilled.
- Part B Risk associated with prolonging bronchoscopy procedure judged to be too high by medical professional.
- Part B Appropriate recent imaging (chest CT within 3 months) not available.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals and the University of Cambridge
Cambridge
About this study
This study investigates the propagation of sound from a source in the chest to the chest wall.
The methodology of the study will be to place a sound source at a known location in the chest and measure the acoustic response on the posterior chest wall with an acoustic sensor array.
Read more
The sound source will be created by playing sound down the working channel of a bronchoscope and located anatomically using direct imaging.
Subjects will be selected for the study by asking patients undergoing a bronchoscopy procedure whether they would be willing to take part in the experiment in addition to their standard procedure.
Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge. The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease, asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally significant interventional bronchoscopy service.
A subsidiary part of the study (Part A) will collect sound recordings from healthy volunteers and patients with common respiratory diseases using the same acoustic sensor array. This is to create a database of lung sounds and quantify inter-subject variability.
The study will last approximately 30 months.
Read the detailed description
The study has two parts, A and B. Both parts are observational studies of the sounds heard at the chest as recorded by an acoustic array.
In Part A, healthy volunteers and patients at Addenbrooke's hospital will have the chest sounds at their back recorded using an electronic-stethoscope array. This will be done in a single session lasting approximately 30 minutes. 50 healthy volunteers and 100 patients will be included.
In Part B, 50 patients undergoing a bronchoscopy at Addenbrooke's hospital will have their bronchoscopy extended by 5-10 minutes so that sounds can be played through the working channel of the bronchoscope and recorded by a microphone array at the posterior chest. Part B will investigate 25 patients with structurally 'normal' lungs (for example patients with Chronic Cough) (Part B(i)), and 25 patients with lung disease that has resulted in an 'abnormal' lung structure (Part B(ii)).
The consultant bronchoscopist will assign the patient to the relevant group based on information from their medical history and their CT scan. For Part B of the study an existing CT scan is an inclusion criterion. CT scans will not be carried out specifically for this study.
- Conditions
- Bronchomalacia, Asthma, Lung Neoplasms, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
- Being tested
- Lung sound transmission measurement, Lung sound recording
- Medical subject headings
- Bronchomalacia, Asthma, Lung Neoplasms, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung sound transmission measurementOther
Sound at chest wall is recorded using a sensor array during the bronchoscopy procedure, while a sound is played down the working channel of the bronchoscope.
Lung sound recordingOther
Lung sounds are recorded using a sensor array.
| Study group | Role | What they receive |
|---|---|---|
| Part A(i) Healthy Volunteers | 50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study. Receives: Other: Lung sound recording | |
| Part A(ii) Patients | 100 patients with wheezing and/or crackles due to respiratory disease. Intervention: Lung sound recording for part A(ii) of the study. Receives: Other: Lung sound recording | |
| Part B(i) 'normal' lung structure | 25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having a 'normal' lung structure.
Intervention: Lung sound transmission measurement for part B(i) of the study. Receives: Other: Lung sound transmission measurement | |
| Part B(ii) 'abnormal' lung structure | 25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having an 'abnormal' lung structure.
Intervention: Lung sound transmission measurement for part B(ii) of the study. Receives: Other: Lung sound transmission measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure.
This will use a hypothesis test on features extracted from the time-series array data in Part B of the study.
Measured: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
Secondary outcomes (2)
Database of acoustic response of human chest to a known sound input within the lungs.
This will consist of acoustic data from an array of acoustic sensors on the posterior back, acoustic data from the sound source, photographs of the back with sensor locations and key anatomical features marked and thorax CT scans. This database will be used to investigate propagation mechanisms and localisation techniques.
Measured: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
Database of lung sound recordings from array on posterior chest.
This will consist of acoustic data from an array of acoustic sensors at the posterior chest of supine participants taken while these perform a series of breathing exercises. The database will also include basic biometric data.
Measured: Will be assessed when all data for Part A of the study has been collected. Up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start14 Feb 2018
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchomalaciaStudies 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
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maximilian Nussbaumer
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Maximilian Nussbaumer, University of Cambridge
- Investigators
- Pasupathy Sivasothy, PhD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043898
- Sponsor's protocol ID
- A093684
- Status last verified
- Nov 2020
- First submitted
- 30 Jan 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable patient data will be used in publications and made available on the University of Cambridge's data repository DSpace when the results of the study are published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Sound Propagation Through the Human Lung for Better Diagnosis
- ClinicalTrials.gov ID
- NCT03043898
- Acronym / sponsor ID
- A093684
- Conditions
- Bronchomalacia, Asthma, Lung Neoplasms, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Maximilian NussbaumerUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 6 Feb 2017 (estimated)
- 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.
This study investigates the propagation of sound from a source in the chest to the chest wall.
The methodology of the study will be to place a sound source at a known location in the chest and measure the acoustic response on the posterior chest wall with an acoustic sensor array.
The sound source will be created by playing sound down the working channel of a bronchoscope and located anatomically using direct imaging.
Subjects will be selected for the study by asking patients undergoing a bronchoscopy procedure whether they would be willing to take part in the experiment in addition to their standard procedure.
Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge. The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease, asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally significant interventional bronchoscopy service.
A subsidiary part of the study (Part A) will collect sound recordings from healthy volunteers and patients with common respiratory diseases using the same acoustic sensor array. This is to create a database of lung sounds and quantify inter-subject variability.
The study will last approximately 30 months.
Detailed description
The study has two parts, A and B. Both parts are observational studies of the sounds heard at the chest as recorded by an acoustic array.
In Part A, healthy volunteers and patients at Addenbrooke's hospital will have the chest sounds at their back recorded using an electronic-stethoscope array. This will be done in a single session lasting approximately 30 minutes. 50 healthy volunteers and 100 patients will be included.
In Part B, 50 patients undergoing a bronchoscopy at Addenbrooke's hospital will have their bronchoscopy extended by 5-10 minutes so that sounds can be played through the working channel of the bronchoscope and recorded by a microphone array at the posterior chest. Part B will investigate 25 patients with structurally 'normal' lungs (for example patients with Chronic Cough) (Part B(i)), and 25 patients with lung disease that has resulted in an 'abnormal' lung structure (Part B(ii)).
The consultant bronchoscopist will assign the patient to the relevant group based on information from their medical history and their CT scan. For Part B of the study an existing CT scan is an inclusion criterion. CT scans will not be carried out specifically for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A(i) Healthy Volunteers | – | Other: Lung sound recording50 healthy volunteers. Intervention: Lung sound recording for part A(i) of the study. |
| Part A(ii) Patients | – | Other: Lung sound recording100 patients with wheezing and/or crackles due to respiratory disease. Intervention: Lung sound recording for part A(ii) of the study. |
| Part B(i) 'normal' lung structure | – | Other: Lung sound transmission measurement25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having a 'normal' lung structure. Intervention: Lung sound transmission measurement for part B(i) of the study. |
| Part B(ii) 'abnormal' lung structure | – | Other: Lung sound transmission measurement25 patients who are scheduled to have a Bronchoscopy as part of their standard care and are identified by a medical professional as having an 'abnormal' lung structure. Intervention: Lung sound transmission measurement for part B(ii) of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Part A(i) 50 healthy volunteers, taken from the general population. Part A(ii) 100 patients, taken from the population of patients at Addenbrooke's Hospital, Cambridge, UK with clear evidence of wheezing and/or crackles due to respiratory disease. We will aim to recruit approximately 50 patients with wheezing and 50 patients with crackles. Part B(i) 25 patients, taken from the population of patients on the bronchoscopy list at Addenbrooke's Hospital, Cambridge, UK. Part B(ii) 25 patients, taken from the population of patients on the bronchoscopy list at Addenbrooke's Hospital, Cambridge, UK
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male of Female, aged 18 years or above.
- Part A(i) Healthy volunteer with no history of smoking, recreational drug use or respiratory disease.
- Part A(ii) Patient admitted to Addenbrooke's with a pulmonary disease resulting in crackles and/or wheezes (as diagnosed by a qualified medical practitioner).
- Part B Patient admitted to Addenbrooke's hospital for a bronchoscopy procedure.
Key exclusion criteria (9 listed)
- Informed consent is not given.
- Subject is under 18 years old.
- WHO performance status >2.
- Subject is pregnant.
- Subject is unable to understand English.
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 |
|---|---|---|
| Lung sound transmission measurementSound at chest wall is recorded using a sensor array during the bronchoscopy procedure, while a sound is played down the working channel of the bronchoscope. | Other | Part B(i) 'normal' lung structure, Part B(ii) 'abnormal' lung structure |
| Lung sound recordingLung sounds are recorded using a sensor array. | Other | Part A(i) Healthy Volunteers, Part A(ii) Patients |
Primary outcome
Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure.
Time frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
This will use a hypothesis test on features extracted from the time-series array data in Part B of the study.
2 secondary outcomes
Database of acoustic response of human chest to a known sound input within the lungs.
Time frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.
Database of lung sound recordings from array on posterior chest.
Time frame: Will be assessed when all data for Part A of the study has been collected. Up to 30 months.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Yes. Non-identifiable patient data will be used in publications and made available on the University of Cambridge's data repository DSpace when the results of the study are published.
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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.
Pasupathy Sivasothy, PhD principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchomalacia and Asthma, run by Maximilian Nussbaumer at 1 site in United Kingdom.
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 9 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: stopped early, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sound propagation through the human chest in subjects with 'normal' and 'abnormal' lung structure. (time frame: Will be assessed when all data for Part B of the study has been collected. Up to 30 months.). 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 5 Nov 2020.