WheezingAIRNCT04208360
Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds
An observational study of Wheezing and Rhonchi, run by StethoMe.
Trial summary
In the present trial, the StethoMe electronic stethoscope will be used for pulmonary auscultation and recording of lung sounds in the pediatric study population. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- What is being tested?
- StethoMe stethoscope
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Oct 2021
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: It is planned to enroll 84 patients into the trial in three trial centers that will be participating in the study. Each center should recruit approximately 33% of study recordings (25-30 patients).
Who may be able to join
- Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward (PL and EU).
- Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward or treated in an outpatient clinic (US).
- Informed consent of parents or caregivers, according to local regulations.
Who cannot join
- Skin/soft tissue disease or local infection at the site of pulmonary auscultation or any other contraindication for the pulmonary auscultation.
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project.
About this study
In the present trial, the StethoMe electronic stethoscope will be used for pulmonary auscultation and recording of lung sounds in the pediatric study population.
Read the detailed description
Multicenter, international - 2 EU sites (max. 1 in Poland) and a single US site.
Trial centers and investigators will be identified and selected based on their clinical and research experience.
The trial objective is to assess whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds in the categories of wheezes, rhonchi, fine crackles and coarse as compared to pulmonary auscultation by experienced physicians (general practitioners (GPs) and pulmonologists).
The recordings will be used to form a gold standard database of lung sounds as evaluated by an expert, independent panel according to the study protocol. The gold standard database will include approximately equal representation of wheezes, rhonchi, fine crackles and coarse crackles. Moreover, the database will also include recordings without any of the previous descripted pathological sounds. The results of these two analyses, by traditional physician listening and by the StethoMe AI software application, will be assessed for sensitivity and specificity to the gold standard database in detection of the four lung sounds and recordings without defined pathological sounds. The StethoMe AI will be considered to provide clinical benefit if it demonstrates statistically better sensitivity or specificity on any of the four lung sounds as compared to the traditional physician auscultation, together with F1 score analysis.
- Conditions
- Wheezing, Rhonchi, Crackle, Lung Sound
- Being tested
- StethoMe stethoscope
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StethoMe stethoscopeDevice
Assessing whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting pulmonary auscultation recordings
Sensitivity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of wheezes by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of wheezes by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of rhonchi by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of coarse crackles by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of fine crackles by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of wheezes by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of rhonchi by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of coarse crackles by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of fine crackles by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of wheezes by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of rhonchi by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of coarse crackles by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of fine crackles by pulmonologists in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of wheezes by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of rhonchi by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of coarse crackles by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Sensitivity for detection of fine crackles by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of wheezes by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of rhonchi by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of coarse crackles by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
Specificity for detection of fine crackles by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of wheezes by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of rhonchi by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of coarse crackles by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
F1 score for detection of fine crackles by general practitioners in comparison to gold standard
Measured: 24 hours
Collecting pulmonary auscultation recordings
- Possibility to perform pulmonary auscultation by physician by using study device with dedicated application, defined as a percentage of enrolled patients in whom the pulmonary auscultation was performed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study startMar 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StethoMe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208360
- Sponsor's protocol ID
- StethoMe AIR
- Acronym
- AIR
- Status last verified
- Oct 2020
- First submitted
- 18 Dec 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds
- ClinicalTrials.gov ID
- NCT04208360
- Acronym / sponsor ID
- AIR / StethoMe AIR
- Conditions
- Wheezing, Rhonchi, Crackle, Lung Sound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- StethoMeIndustry (pharma, biotech, devices)
- Study start
- Mar 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 23 Dec 2019 (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.
In the present trial, the StethoMe electronic stethoscope will be used for pulmonary auscultation and recording of lung sounds in the pediatric study population.
Detailed description
Multicenter, international - 2 EU sites (max. 1 in Poland) and a single US site.
Trial centers and investigators will be identified and selected based on their clinical and research experience.
The trial objective is to assess whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds in the categories of wheezes, rhonchi, fine crackles and coarse as compared to pulmonary auscultation by experienced physicians (general practitioners (GPs) and pulmonologists).
The recordings will be used to form a gold standard database of lung sounds as evaluated by an expert, independent panel according to the study protocol. The gold standard database will include approximately equal representation of wheezes, rhonchi, fine crackles and coarse crackles. Moreover, the database will also include recordings without any of the previous descripted pathological sounds. The results of these two analyses, by traditional physician listening and by the StethoMe AI software application, will be assessed for sensitivity and specificity to the gold standard database in detection of the four lung sounds and recordings without defined pathological sounds. The StethoMe AI will be considered to provide clinical benefit if it demonstrates statistically better sensitivity or specificity on any of the four lung sounds as compared to the traditional physician auscultation, together with F1 score analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- It is planned to enroll 84 patients into the trial in three trial centers that will be participating in the study. Each center should recruit approximately 33% of study recordings (25-30 patients).
Key inclusion criteria (3 listed)
- Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward (PL and EU).
- Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward or treated in an outpatient clinic (US).
- Informed consent of parents or caregivers, according to local regulations.
Key exclusion criteria (2 listed)
- Skin/soft tissue disease or local infection at the site of pulmonary auscultation or any other contraindication for the pulmonary auscultation.
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project.
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 |
|---|---|---|
| StethoMe stethoscopeAssessing whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds. | Device | – |
Primary outcome
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of wheezes by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of wheezes by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of rhonchi by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of coarse crackles by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of fine crackles by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of wheezes by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of rhonchi by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of coarse crackles by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of fine crackles by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of wheezes by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of rhonchi by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of coarse crackles by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of fine crackles by pulmonologists in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of wheezes by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of rhonchi by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of coarse crackles by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Sensitivity for detection of fine crackles by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of wheezes by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of rhonchi by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of coarse crackles by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
Specificity for detection of fine crackles by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of wheezes by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of rhonchi by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of coarse crackles by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
F1 score for detection of fine crackles by general practitioners in comparison to gold standard
Collecting pulmonary auscultation recordings
Time frame: 24 hours
- Possibility to perform pulmonary auscultation by physician by using study device with dedicated application, defined as a percentage of enrolled patients in whom the pulmonary auscultation was performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Wheezing
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Not yet recruitingPhase 4
Prevent Wheeze Trial
Lower Respiratory Tract Infection (LRTI), Recurrent Wheezing
RecruitingPhase 3
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Wheezing, LRTI
RecruitingObservational study
N-WATCH: Nottingham Wheeze Assessment in Tidal Children
Asthma in Children
Not yet recruitingPhase 1/2
Genes, Soy Isoflavones, and Virus
Wheezing
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing and Rhonchi, run by StethoMe.
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 3 inclusion and 2 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 22 Oct 2020. 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?
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?
Collecting pulmonary auscultation recordings (time frame: 24 hours). The study lists 37 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 22 Oct 2020.