Pulmonary FibrosisATF/SPPNCT06399094
Frequency-time Analysis of Pathological Lung Sounds: Detection and Quantification of Pathological Sounds in Patients With Cystic Fibrosis, Pulmonary Fibrosis or COPD (Chronic Obstructive Pulmonary Disease)
An observational study of Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites in France.
Trial summary
The main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, COPD or pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis
- What is being tested?
- Lung sound recordings
- How many people
- 23 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jul 2024to 30 Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be recruited during a consultation scheduled as part of the usual follow-up of their pathology in the pneumology department of mulhouse hospital center and strasbourg university hospital center.
Who may be able to join
- Age ≥ 18 years
- Suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, COPD
- Not opposed to participating in the study
Who cannot join
- Person under court protection, guardianship or curatorship
- Person deprived of liberty by judicial or administrative decision
- Patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion.
Trial locations and contacts
2 sites in 1 country.
France2 sites
GHRMSA - Hôpital Emile Muller
Mulhouse, Haut-Rhin, 68100
Hôpitaux Universitaire de Strasbourg
Strasbourg, Bas-Rhin, 67000
About this study
The main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, COPD or pulmonary fibrosis.
Read the detailed description
Secondary objectives
The other objectives of this study are :
- To evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation.
- To evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method.
Conduct of research This is a single-center, non-randomized, open-label study involving 60 male and female patients aged 18 to 65, eligible for a scheduled consultation as part of their usual pathological follow-up (routine care).
Lung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition.
Recordings will be made using a 3M Littmann© model 3200 electronic stethoscope. The stethoscope works with Eko software, which will be installed on a touch-sensitive tablet or computer, enabling local storage of recorded data.
Whatever the patient's pathology, the physician will listen to 10 lung sites defined in the protocol. At least one breath per pulmonary site will be recorded during the consultation.
If a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed.
- Being tested
- Lung sound recordings
- Medical subject headings
- Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung sound recordingsOther
The lung sound recordings will be made during a consultation scheduled as part of the patient's usual follow-up, after obtaining the patient's non-opposition.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary fibrosis | Not described Receives: Other: Lung sound recordings | |
| Chronic Obstructive Pulmonary Disease | Not described Receives: Other: Lung sound recordings | |
| Cystic fibrosis | Not described Receives: Other: Lung sound recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung sounds visible in their representation as time-frequency images
Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.
Measured: At inclusion
Secondary outcomes (1)
Classification of sounds by severity
Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start18 Jul 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Why it stopped: Recruitment issue
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399094
- Sponsor's protocol ID
- GHRMSA 1315
- Acronym
- ATF/SPP
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency-time Analysis of Pathological Lung Sounds: Detection and Quantification of Pathological Sounds in Patients With Cystic Fibrosis, Pulmonary Fibrosis or COPD (Chronic Obstructive Pulmonary Disease)
- ClinicalTrials.gov ID
- NCT06399094
- Acronym / sponsor ID
- ATF/SPP / GHRMSA 1315
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment issue
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 3 May 2024 (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 main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, COPD or pulmonary fibrosis.
Detailed description
Secondary objectives
The other objectives of this study are :
- To evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation.
- To evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method.
Conduct of research This is a single-center, non-randomized, open-label study involving 60 male and female patients aged 18 to 65, eligible for a scheduled consultation as part of their usual pathological follow-up (routine care).
Lung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition.
Recordings will be made using a 3M Littmann© model 3200 electronic stethoscope. The stethoscope works with Eko software, which will be installed on a touch-sensitive tablet or computer, enabling local storage of recorded data.
Whatever the patient's pathology, the physician will listen to 10 lung sites defined in the protocol. At least one breath per pulmonary site will be recorded during the consultation.
If a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary fibrosis | – | Other: Lung sound recordings |
| Chronic Obstructive Pulmonary Disease | – | Other: Lung sound recordings |
| Cystic fibrosis | – | Other: Lung sound recordings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be recruited during a consultation scheduled as part of the usual follow-up of their pathology in the pneumology department of mulhouse hospital center and strasbourg university hospital center.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, COPD
- Not opposed to participating in the study
Key exclusion criteria (3 listed)
- Person under court protection, guardianship or curatorship
- Person deprived of liberty by judicial or administrative decision
- Patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion.
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 recordingsThe lung sound recordings will be made during a consultation scheduled as part of the patient's usual follow-up, after obtaining the patient's non-opposition. | Other | Chronic Obstructive Pulmonary Disease, Cystic fibrosis, Pulmonary fibrosis |
Primary outcome
Lung sounds visible in their representation as time-frequency images
Time frame: At inclusion
Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.
1 secondary outcome
Classification of sounds by severity
Time frame: At inclusion
Results and safety
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites in France.
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 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: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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: Recruitment issue). 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?
Lung sounds visible in their representation as time-frequency images (time frame: At inclusion). 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 17 Nov 2025.