Respiratory SoundsNCT01156818
Wheezometer™ Exploratory (WM) Field Study
An observational study of Respiratory Sounds and Wheezing, run by KarmelSonix Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Respiratory Sounds, Wheezing
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asthma patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, 90025
Ross Wilson, 909-989-0033, rossw@karmelsoinx.com
Sheldon Spector, Prof.
About this study
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.
- Conditions
- Respiratory Sounds, Wheezing
- Keywords
- Wheeze measurements
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Age 8-21 years | |
| Adult | Age 21-80 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wz% change in response to BD. Symptom score by e-Diary; Spirometer - FEV1.0/FVC/PEF/MEF50 with automated storage and timing
Measured: 2 weeks
Secondary outcomes (1)
Correlate Wz% to FEV1.0: within patient correlation
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory SoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KarmelSonix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ross Wilson, Study director, KarmlSonix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156818
- Sponsor's protocol ID
- KSI-MUL-GEN-WMF-01
- Status last verified
- Jul 2010
- First submitted
- 2 Jul 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheezometer™ Exploratory (WM) Field Study
- ClinicalTrials.gov ID
- NCT01156818
- Acronym / sponsor ID
- KSI-MUL-GEN-WMF-01
- Conditions
- Respiratory Sounds, Wheezing
- Keywords
- Wheeze measurements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KarmelSonix Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Age 8-21 years |
| Adult | – | –Age 21-80 years |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthma patients
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Correlate Wz% to FEV1.0: within patient correlation
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
Related trials for Respiratory Sounds
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Not yet recruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
Not yet recruitingPhase 4
Prevent Wheeze Trial
Lower Respiratory Tract Infection (LRTI), Recurrent Wheezing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Wilson study director
KarmlSonix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Sounds and Wheezing, run by KarmelSonix Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ross Wilson (909-989-0033, rossw@karmelsoinx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.