WheezoMeter® Correlation Study

This study has been terminated.
(Device revised)
Sponsor:
Information provided by (Responsible Party):
iSonea
ClinicalTrials.gov Identifier:
NCT01556958
First received: March 15, 2012
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.


Condition
Asthma
Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.

Resource links provided by NLM:


Further study details as provided by iSonea:

Enrollment: 19
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Active Wheezing - age 5-12
Active Wheezing - under age 5
No Wheezing

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric Specialty Clinic

Criteria

Inclusion Criteria:

  • Patients <= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.

Control:

  • Patients <= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.

Exclusion Criteria:

  • Medical problems that would contraindicate Wz% measurement.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556958

Locations
United States, California
Site 1
Folsom, California, United States, 95630
Sponsors and Collaborators
iSonea
  More Information

No publications provided

Responsible Party: iSonea
ClinicalTrials.gov Identifier: NCT01556958     History of Changes
Other Study ID Numbers: iS-2012-Wz
Study First Received: March 15, 2012
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 29, 2014