PneumothoraxCLSANCT02771184
Computerized Lung Sound Analysis
A study testing Lung Sound Recording System in people with Pneumothorax and Pulmonary Fibrosis, run by Smolle-Juettner Freyja, Prof MD at 1 site in Austria.
Trial summary
This clinical trial is conducted within the research project 'Computerized Lung Sound Analysis'. The research goal is the development of a system enabling the automatic classification of lung sounds, which will result in a decision support system for physicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumothorax, Pulmonary Fibrosis
- What is being tested?
- Lung Sound Recording System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2016to Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- General:
- Smoker and non-smoker
- 'Lung-healthy' subjects (control group), subjects with pneumothorax or subjects with pulmonary fibrosis
- Additional for 'lung-healthy' subjects:
- COPD < 3 (GOLD Criteria)
Who cannot join
- General:
- Body Mass Index > 30
- Preceding thoracic surgery
- Non-cooperation of the subject
- Intubated or tracheostomized subjects
- Additional for 'lung-healthy' subjects:
- Disease of the respiratory system
- Taking medication influencing the respiration
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial is conducted within the research project 'Computerized Lung Sound Analysis'. The research goal is the development of a system enabling the automatic classification of lung sounds, which will result in a decision support system for physicians.
The objective of this trial is to create a small lung sound corpus, enabling the development of a prototype of the described system. Therefore, investigators record lung sounds with several lung sound transducers distributed on the posterior chest of human test subjects.
Read the detailed description
In this clinical trial investigators record lung sounds over the posterior chest of human test subjects. The subjects are either lung-healthy (control group) or subjects with pneumothorax condition or pulmonary fibrosis. The lung sounds are recorded in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. For each subject investigators simultaneously record 30 seconds of the airflow signal and the lung sounds from 16 lung sound transducers.
- Conditions
- Pneumothorax, Pulmonary Fibrosis
- Being tested
- Lung Sound Recording System
- Medical subject headings
- Pneumothorax, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Sound Recording SystemDevice
The lung sounds are recorded over the posterior chest in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. Therefore, they receive a real-time feedback for the airflow rate. The airflow signal and the lung sounds from 16 lung sound transducers are recorded simultaneously for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Lung-Healthy | Other | Subjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System. Receives: Device: Lung Sound Recording System |
| Pneumothorax | Other | Subjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System. Receives: Device: Lung Sound Recording System |
| Pulmonary Fibrosis | Other | Subjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System. Receives: Device: Lung Sound Recording System |
What is being measured
The primary outcome is the main question the study is designed to answer.
16-Channel Lung Sound Recordings and synchronous Airflow Recording
The lung sounds and the airflow signal are simultaneously recorded with the Lung Sound Recording System. One time frame contains several breathing phases. Depending on the lung disease normal lung sounds are either altered or adventitious lung sounds are superimposed.
Measured: 30 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smolle-Juettner Freyja, Prof MD
- Sponsor type
- University, hospital or other
- Collaborators
- Graz University of Technology
- Responsible party
- Sponsor-investigator, Smolle-Juettner Freyja, Prof MD, Medical University of Graz
- Investigators
- Freyja-Maria Smolle-Juettner, Univ.-Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771184
- Sponsor's protocol ID
- 28-088 ex 15/16
- Acronym
- CLSA
- Status last verified
- May 2019
- First submitted
- 22 Apr 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Lung Sound Analysis
- ClinicalTrials.gov ID
- NCT02771184
- Acronym / sponsor ID
- CLSA / 28-088 ex 15/16
- Conditions
- Pneumothorax, Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Smolle-Juettner Freyja, Prof MDUniversity, hospital or other
- Collaborators
- Graz University of Technology
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 13 May 2016 (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 clinical trial is conducted within the research project 'Computerized Lung Sound Analysis'. The research goal is the development of a system enabling the automatic classification of lung sounds, which will result in a decision support system for physicians.
The objective of this trial is to create a small lung sound corpus, enabling the development of a prototype of the described system. Therefore, investigators record lung sounds with several lung sound transducers distributed on the posterior chest of human test subjects.
Detailed description
In this clinical trial investigators record lung sounds over the posterior chest of human test subjects. The subjects are either lung-healthy (control group) or subjects with pneumothorax condition or pulmonary fibrosis. The lung sounds are recorded in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. For each subject investigators simultaneously record 30 seconds of the airflow signal and the lung sounds from 16 lung sound transducers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung-Healthy | Other | Device: Lung Sound Recording SystemSubjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System. |
| Pneumothorax | Other | Device: Lung Sound Recording SystemSubjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System. |
| Pulmonary Fibrosis | Other | Device: Lung Sound Recording SystemSubjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Smoker and non-smoker
- 'Lung-healthy' subjects (control group), subjects with pneumothorax or subjects with pulmonary fibrosis
- COPD < 3 (GOLD Criteria)
Key exclusion criteria (8 listed)
- Body Mass Index > 30
- Preceding thoracic surgery
- Non-cooperation of the subject
- Intubated or tracheostomized subjects
- Disease of the respiratory system
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 Recording SystemThe lung sounds are recorded over the posterior chest in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. Therefore, they receive a real-time feedback for the airflow rate. The airflow signal and the lung sounds from 16 lung sound transducers are recorded simultaneously for 30 seconds. | Device | Lung-Healthy, Pneumothorax, Pulmonary Fibrosis |
Primary outcome
16-Channel Lung Sound Recordings and synchronous Airflow Recording
Time frame: 30 Seconds
The lung sounds and the airflow signal are simultaneously recorded with the Lung Sound Recording System. One time frame contains several breathing phases. Depending on the lung disease normal lung sounds are either altered or adventitious lung sounds are superimposed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- 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.
Freyja-Maria Smolle-Juettner, Univ.-Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Sound Recording System in people with Pneumothorax and Pulmonary Fibrosis, run by Smolle-Juettner Freyja, Prof MD at 1 site in Austria.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 20 May 2019. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
16-Channel Lung Sound Recordings and synchronous Airflow Recording (time frame: 30 Seconds). 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 20 May 2019.