NCT00495430

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

First QC Date

July 1, 2007

Last Update Submit

June 15, 2009

Conditions

Healthy

Keywords

HealthyLung soundsBreath sounds

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 310196, Israel

Location

Related Publications (2)

  • 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.

    PMID: 17551264BACKGROUND

  • 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.

    PMID: 1745848BACKGROUND

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mordechai Yigla, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 1, 2007

First Posted

July 3, 2007

Study Start

December 1, 2004

Study Completion

July 1, 2009

Last Updated

June 16, 2009

Record last verified: 2009-06

Locations

IL(1)