Wheezometer™ Exploratory (WM) Field Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
KarmelSonix Ltd.

Brief Summary:

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
Observational Model: Case-Only
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Correlate Wz% to FEV1.0: within patient correlation [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asthma patients

Inclusion Criteria:

  • Physician diagnosed asthma.
  • Poorly controlled asthma as per GINA Guidelines with frequent (i.e. >5/week) use of reliever medications.
  • Adequate comprehension level and demonstrated ability to perform unsupervised spirometry, wheezometry and use the symptom diary.
  • Age range 8-80. Patients over 40 will only be included if they are lifetime non-smokers, who have demonstrated reversibility of airway obstruction (at least 12% improvement in FEV1.0 after bronchodilator).
  • All patients included in the study will be routinely receiving either a short acting bronchodilator or a long acting bronchodilator twice daily as part of their regular medication. Additional doses of bronchodilator will be taken on an as needed basis. No change in regular medication will be made for the purposes of the study.
  • Subject or subject's parents/guardians is/are able to comprehend and give informed consent for participation in the study.

Consent of treating physician.

Exclusion Criteria:

  • Inability to perform spirometry and/or Wheezometry. Skin Disorder (burn, infection, or allergy) over upper chest (Child) or neck (Adult).
  • Patients with other diseases, which in the opinion of the treating physician would interfere with the management of asthma and performance of the study according to the protocol.
  • Hospitalization at recruitment, [patients who get admitted while participating will continue to participate].

P- hysician objection.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01156818

Contact: Ross Wilson 909-989-0033

United States, California
California Allergy and Asthma Medical Group, Inc. Recruiting
Los Angeles, California, United States, 90025
Contact: Ross Wilson    909-989-0033   
Principal Investigator: Sheldon Spector, Prof.         
Sponsors and Collaborators
KarmelSonix Ltd.
Study Director: Ross Wilson KarmlSonix

Responsible Party: Ross Wilson, KarmelSonix Identifier: NCT01156818     History of Changes
Other Study ID Numbers: KSI-MUL-GEN-WMF-01
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: July 2010

Keywords provided by KarmelSonix Ltd.:
Wheeze measurements

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms