Wheezometer™ Exploratory (WM) Field Study
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Respiratory Sounds Wheezing |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Wheezometer™ Exploratory (WM) Field Study |
- 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 ] [ Designated as safety issue: No ]
- Correlate Wz% to FEV1.0: within patient correlation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Children
Age 8-21 years
|
|
Adult
Age 21-80 years
|
Eligibility| Ages Eligible for Study: | 8 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Ross Wilson | 909-989-0033 | rossw@karmelsoinx.com |
| United States, California | |
| California Allergy and Asthma Medical Group, Inc. | Recruiting |
| Los Angeles, California, United States, 90025 | |
| Contact: Ross Wilson 909-989-0033 rossw@karmelsoinx.com | |
| Principal Investigator: Sheldon Spector, Prof. | |
| Study Director: | Ross Wilson | KarmlSonix |
More Information
No publications provided
| Responsible Party: | Ross Wilson, KarmelSonix |
| ClinicalTrials.gov Identifier: | NCT01156818 History of Changes |
| Other Study ID Numbers: | KSI-MUL-GEN-WMF-01 |
| Study First Received: | July 2, 2010 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by KarmelSonix Ltd.:
|
Wheeze measurements |
Additional relevant MeSH terms:
|
Respiratory Sounds Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on October 17, 2012
