CoughNCT00907491
Accuracy of Cough Detection in Healthy Adults
An observational study of Cough, run by KarmelSonix Ltd. at 1 site in Israel.
Trial summary
Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- pulmonary sounds analyzer
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to Jul 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults 21 years and above
Who may be able to join
- Patient signed informed consent
- Patients above 21 years old
- No medical history
Who cannot join
- Skin lesions precluding attachment of sensors
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Objective Cough Counting Device to Assess the Accuracy of Cough Detection in Healthy Adults Simulating Cough in Different Postures, Mobility and Environmental Conditions
Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient.
People with respiratory infection, asthmatic patients and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
Read more
Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.
The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.
- Conditions
- Cough
- Being tested
- pulmonary sounds analyzer
- Keywords
- Cough, Wheeze Rate, Respiratory Function Tests
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary sounds analyzerDevice
Cough counting device based on the WIM Technology
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Device: pulmonary sounds analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KarmelSonix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907491
- Sponsor's protocol ID
- WIM-CC 01
- Status last verified
- May 2009
- First submitted
- 21 May 2009
- 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
- Use of Objective Cough Counting Device to Assess the Accuracy of Cough Detection in Healthy Adults Simulating Cough in Different Postures, Mobility and Environmental Conditions
- ClinicalTrials.gov ID
- NCT00907491
- Acronym / sponsor ID
- WIM-CC 01
- Conditions
- Cough
- Keywords
- Cough, Wheeze Rate, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- KarmelSonix Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 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.
Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient.
People with respiratory infection, asthmatic patients and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.
The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: pulmonary sounds analyzer |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults 21 years and above
Key inclusion criteria (3 listed)
- Patient signed informed consent
- Patients above 21 years old
- No medical history
Key exclusion criteria (2 listed)
- Skin lesions precluding attachment of sensors
- Pregnancy
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 |
|---|---|---|
| pulmonary sounds analyzerCough counting device based on the WIM Technology | Device | A |
Primary outcome
To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions
Time frame: within 2 weeks
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 9 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cough, 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 3 inclusion and 2 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 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 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?
To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions (time frame: within 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; AzTrials last refreshed its copy on 7 Nov 2026.