NCT00711399

Brief Summary

The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 18, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

June 18, 2008

Last Update Submit

September 13, 2010

Conditions

Keywords

Respiratory soundsWheezeCough

Outcome Measures

Primary Outcomes (1)

  • Respiratory sounds recordings

    1 hour

Study Arms (1)

group A

Study group

Device: PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies

Interventions

wheeze and cough detection in hospitalized patients.

group A

Eligibility Criteria

Age1 Year - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of children with respiratory infection, asthmatic children and CF patients who suffer from respiratory symptoms such as cough and and/or shortness of breath.

You may qualify if:

  • Patient and/or parents/guardian signed informed consent
  • Patients with cough or shortness of breath

You may not qualify if:

  • Chest tubes
  • Skin lesions precluding attachment of sensors
  • Respiratory distress
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

Related Links

MeSH Terms

Conditions

Respiratory SoundsCough

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Yulia Goryachev, BSc

    KarmelSonix Ltd.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2008

First Posted

July 8, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations