HealthyNCT00495430
Vibration Response Imaging in Healthy Subjects
An observational study of Healthy, run by Deep Breeze at 1 site in Israel.
Trial summary
The primary purpose is to test intersubject variability and establish the qualitative features of normal VRI images and the range of normality of the VRI quantitative lung data values that may be used to differentiate normal from abnormal breath sound distribution. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 310 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2004to Jul 2009
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects who presented for complete physical examination as required by place of employment. Convenience sample - consecutive healthy subjects who meet study criteria are included in the study.
Who may be able to join
- Able and willing to read, understands, and provides written Informed Consent;
- Male or Female in the age range of 18-85 years;
- Subject is healthy and has not exhibited symptoms of acute respiratory tract disease for the past two months;
- Subject has normal chest X-ray and normal lung function during the past 6 months that were judged stable;
- BMI > 21.
Who cannot join
- Subject has a history of a chronic condition that affects the lungs or heart (e.g.chronic obstructive pulmonary disease, asthma, congestive heart failure) or is suspected of having such a condition;
- Subject has a chest cage deformation;
- Subject has spine deformation (including severe scoliosis);
- Subject is Hirsute;
- Subject has a skin lesion (potentially contagious) on the back;
- Subject has a cardiac pacemaker or implantable defibrillator;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects
The primary purpose is to test intersubject variability and establish the qualitative features of normal VRI images and the range of normality of the VRI quantitative lung data values that may be used to differentiate normal from abnormal breath sound distribution. Our hypothesis was that VRI breath sound images of healthy subjects are similar in a qualitative and quantitative manner.
Read the detailed description
Computerized analyses have shown that normal lung sounds have distinctive characteristic that can be differentiated from abnormal lung sounds.However, technical issues and complicated display modes have restricted the use of computerized lung sound analyses in the clinical environment.
The VRI provides dynamic gray-scale images and quantitative lung data showing the breath sound distribution of healthy individuals. Typical features that are discerned by trained raters and quantitative lung data may serve as a reference for comparison to abnormal breath sound images.
- Conditions
- Healthy
- Keywords
- Healthy, Lung sounds, Breath sounds
- Medical subject headings
- Respiratory Sounds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startDec 2004
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Breeze
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mordechai Yigla, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495430
- Sponsor's protocol ID
- DB013
- Status last verified
- Jun 2009
- First submitted
- 1 Jul 2007
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
PubMed 17551264Ploysongsang Y, Iyer VK, Ramamoorthy PA. Reproducibility of the vesicular breath sounds in normal subjects. Respiration. 1991;58(3-4):158-62. doi: 10.1159/000195918.
PubMed 1745848
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00495430
- Acronym / sponsor ID
- DB013
- Conditions
- Healthy
- Keywords
- Healthy, Lung sounds, Breath sounds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Deep BreezeIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Jul 2009 (estimated)
- First posted
- 3 Jul 2007 (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.
The primary purpose is to test intersubject variability and establish the qualitative features of normal VRI images and the range of normality of the VRI quantitative lung data values that may be used to differentiate normal from abnormal breath sound distribution. Our hypothesis was that VRI breath sound images of healthy subjects are similar in a qualitative and quantitative manner.
Detailed description
Computerized analyses have shown that normal lung sounds have distinctive characteristic that can be differentiated from abnormal lung sounds.However, technical issues and complicated display modes have restricted the use of computerized lung sound analyses in the clinical environment.
The VRI provides dynamic gray-scale images and quantitative lung data showing the breath sound distribution of healthy individuals. Typical features that are discerned by trained raters and quantitative lung data may serve as a reference for comparison to abnormal breath sound images.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects who presented for complete physical examination as required by place of employment. Convenience sample - consecutive healthy subjects who meet study criteria are included in the study.
Key inclusion criteria (5 listed)
- Able and willing to read, understands, and provides written Informed Consent;
- Male or Female in the age range of 18-85 years;
- Subject is healthy and has not exhibited symptoms of acute respiratory tract disease for the past two months;
- Subject has normal chest X-ray and normal lung function during the past 6 months that were judged stable;
- BMI > 21.
Key exclusion criteria (6 listed)
- Subject has a history of a chronic condition that affects the lungs or heart (e.g.chronic obstructive pulmonary disease, asthma, congestive heart failure) or is suspected of having such a condition;
- Subject has a chest cage deformation;
- Subject has spine deformation (including severe scoliosis);
- Subject is Hirsute;
- Subject has a skin lesion (potentially contagious) on the back;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
- Background: PubMed 17551264Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
- Background: PubMed 1745848Ploysongsang Y, Iyer VK, Ramamoorthy PA. Reproducibility of the vesicular breath sounds in normal subjects. Respiration. 1991;58(3-4):158-62. doi: 10.1159/000195918.
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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.
Mordechai Yigla, MD principal investigator
Rambam Health Care Campus
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 Healthy, run by Deep Breeze at 1 site in Israel.
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 6 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 Jun 2009. 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 Israel. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495430, which also lists 2 linked publications.
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 Jun 2009.