AsthmaNCT00901433
Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
An observational study of Asthma, run by KarmelSonix Ltd. at 1 site in Israel.
Trial summary
The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Personal WheezoMeter
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Apr 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male/Female participants ages 18 and up that were either diagnosed as an asthmatic or are parent/guardian of an asthmatic child age under 18 years.
Who may be able to join
- Male/female age 18 years and up.
- Subject is diagnosed as an asthmatic, or subject is parent/guardian of an asthmatic child age under 18 years.
- Subject understands the study procedure.
- Subject is able to read the User Manual.
- Signed Informed Consent form
- Compliance with study requirements.
Who cannot join
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. Furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty.
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. This usability study was designed to test independent home use and device interface effectiveness of the Personal WheezoMeter in order to validate its safe and effective use by intended users.
- Conditions
- Asthma
- Being tested
- Personal WheezoMeter
- Keywords
- Asthma, Wheeze Rate, Respiratory Function Tests
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal WheezoMeterDevice
pulmonary sounds analyzer
| Study group | Role | What they receive |
|---|---|---|
| A | Usability study of the Personal Wheezometer Receives: Device: Personal WheezoMeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be evaluated by success rate of task performance.
Measured: At the end of the study meeting
Secondary outcomes (2)
Number of questions addressed to the investigator required by the participant in order to complete tasks.
Measured: during the study
User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems.
Measured: At the end of the study meeting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KarmelSonix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanna Levy, Dr., Study director, KarmelSonix Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901433
- Sponsor's protocol ID
- KSI-PW-US-01
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Operating of the Personal WheezoMeter by Intended Users - A Usability Study
- ClinicalTrials.gov ID
- NCT00901433
- Acronym / sponsor ID
- KSI-PW-US-01
- Conditions
- Asthma
- Keywords
- Asthma, Wheeze Rate, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KarmelSonix Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 May 2009 (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.
The NAEPP (National Asthma Education and Prevention Program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. Unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. Furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty.
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. This usability study was designed to test independent home use and device interface effectiveness of the Personal WheezoMeter in order to validate its safe and effective use by intended users.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Personal WheezoMeterUsability study of the Personal Wheezometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male/Female participants ages 18 and up that were either diagnosed as an asthmatic or are parent/guardian of an asthmatic child age under 18 years.
Key inclusion criteria (6 listed)
- Male/female age 18 years and up.
- Subject is diagnosed as an asthmatic, or subject is parent/guardian of an asthmatic child age under 18 years.
- Subject understands the study procedure.
- Subject is able to read the User Manual.
- Signed Informed Consent form
Key exclusion criteria (3 listed)
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal WheezoMeterpulmonary sounds analyzer | Device | A |
Primary outcome
Safety will be evaluated by success rate of task performance.
Time frame: At the end of the study meeting
2 secondary outcomes
Number of questions addressed to the investigator required by the participant in order to complete tasks.
Time frame: during the study
User satisfaction will be evaluated by questionnaire that focuses on subjective impressions regarding usability and potential safety problems.
Time frame: At the end of the study meeting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
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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.
Hanna Levy, Dr. study director
KarmelSonix Ltd.
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 Asthma, run by KarmelSonix Ltd. at 1 site in Israel.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jun 2009. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be evaluated by success rate of task performance. (time frame: At the end of the study meeting). 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 24 Jun 2009.