Vibration Response Imaging in Healthy Subjects (NCT00495430)

Study 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. 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 studied

Healthy

Keywords

Healthy
Lung sounds
Breath sounds

In context

Lead sponsor

Deep Breeze is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 310 participants (estimated)

Study locations

1 site

Rambam Medical Center
Haifa, 310196, Israel

References and documents

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 17551264 ↗
Ploysongsang 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00495430
Lead sponsor: Deep Breeze
First posted: Jul 3, 2007
Start date: Dec 2004
Completion: Jul 2009 (estimated)
Last update: Jun 16, 2009

Study contacts

Mordechai Yigla, MD

principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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Vibration Response Imaging in Healthy Subjects