Wheezometer™ Exploratory (WM) Field Study
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|ClinicalTrials.gov Identifier: NCT01156818|
Recruitment Status : Unknown
Verified July 2010 by KarmelSonix Ltd..
Recruitment status was: Recruiting
First Posted : July 5, 2010
Last Update Posted : June 9, 2011
Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed healthcare professional. The device is intended for use with pediatric and adult patients in both home and clinical settings.
The purpose of the study is to determine whether Wz% and change in Wz% correlate with symptoms and change in symptoms at least as well as FEV1 and change in FEV1.0. Additional information to be obtained from the study will be to determine whether there is a symptom threshold at which a patient seeks rescue medications and if so, to determine the value of Wz% and FEV1.0 at this point (Wz%, FEV1.0 thresholds). The study will also provide information on the within patient and whole group correlations between Wz% and FEV.
|Condition or disease|
|Respiratory Sounds Wheezing|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Wheezometer™ Exploratory (WM) Field Study|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||December 2011|
Age 8-21 years
Age 21-80 years
- Wz% change in response to BD. Symptom score by e-Diary; Spirometer - FEV1.0/FVC/PEF/MEF50 with automated storage and timing [ Time Frame: 2 weeks ]
- Correlate Wz% to FEV1.0: within patient correlation [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156818
|Contact: Ross Wilsonfirstname.lastname@example.org|
|United States, California|
|California Allergy and Asthma Medical Group, Inc.||Recruiting|
|Los Angeles, California, United States, 90025|
|Contact: Ross Wilson 909-989-0033 email@example.com|
|Principal Investigator: Sheldon Spector, Prof.|
|Study Director:||Ross Wilson||KarmlSonix|