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Respiratory SoundsNCT00711399

Assessment of Cough and Wheeze With Breath Sound Documenting Device

An observational study of Respiratory Sounds, run by Carmel Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment. Read more about this study

Who is it for?
Ages 1 year to 45 years
Conditions the study is for
Respiratory Sounds
What is being tested?
PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies
Type of treatment
Medical device
How many people
55 participants
Where
1 siteIsrael
Study dates
Sep 2008to Sep 2010
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 1 year to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The study population will consist of children with respiratory infection, asthmatic children and CF patients who suffer from respiratory symptoms such as cough and and/or shortness of breath.

Who may be able to join

  • Patient and/or parents/guardian signed informed consent
  • Patients with cough or shortness of breath

Who cannot join

  • Chest tubes
  • Skin lesions precluding attachment of sensors
  • Respiratory distress
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Carmel Medical Center

    Haifa, 34362

Other trials in Israel

About this study

Official title: Use of Objective Cough Counting and Breath Sounds Documenting Device, to Assess the Severity and Duration of Cough and Wheeze in Children and Adults Suffer From Acute or Chronic Respiratory Disease.

The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.

Read the detailed description

Clinical background Respiratory wheezes are a characteristic symptom of asthma and other obstructive diseases. The wheezes can be heard on the chest surface and on the trachea using a stethoscope or by listening near the person's mouth. The wheezes are a part of the Continuous Adventitious Breath Sounds (CABS) family, in addition to the wheezes, the rhonchi and the whistles are also a part of this family. Each breath sound has its own unique characteristics but all of them indicate a presence of an airway obstruction. Reducing the obstruction by bronco dilators, for example, lowers the amount of wheezes; meaning lowers the time period during the breathing when wheeze is present.

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.

Children with respiratory infection, asthmatic children and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.

Recently a breakthrough in continuous monitoring of respiratory symptoms was introduced. The Wheezing Infant Monitor (WIM) is a technology that utilizes a flat coin shape microphone that is attached to the chest and over the trachea and allows a continuous recording of the breath sounds absorbed by the microphone. This innovative technology provides an objective assessment of the duration, intensity and timing of the respiratory symptoms after a computerized processing of the data.

Study background The study title is 'Use of objective cough counting and breath sounds documenting device, to assess the severity and duration of cough and wheeze in children and adults suffer from acute or chronic respiratory disease'. The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.

The study is an open study. Each patient will be evaluated twice during each day of hospitalization. Each recording session will last about one hour and include 10 minutes of pre treatment recording, administration of the treatment and continuation of the recording. The patient will be treated according to his/her condition and the recording will not delay the administration of the treatment in urgent cases.

The study population will consist of children with respiratory infection, asthmatic children and CF patients who suffer from respiratory symptoms such as cough and/or shortness of breath. The study population will include approximately 200 patients.

Patients with cough, wheeze or shortness of breath and patients (or their parents/guardians) who gave their consent to participate in the study will be included. Subjects who are in respiratory distress, have skin lesions precluding attachment of sensors, subject with chest tubes and pregnant women will be excluded from the study.

Being tested
PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies
Keywords
Respiratory sounds, Wheeze, Cough
Medical subject headings
Respiratory Sounds, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ TechnologiesDevice

    wheeze and cough detection in hospitalized patients.

Study groups in NCT00711399
Study groupRoleWhat they receive
group AStudy group
Receives: Device: PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory sounds recordings

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2009
  4. Study completionSep 2010

Resources

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-control
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711399
Sponsor's protocol ID
CMC 07-0063
Status last verified
Sep 2010
First submitted
18 Jun 2008
Last updated
14 Sep 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Sounds, run by Carmel Medical Center 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 2 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: finished, as of the sponsor's last update on 14 Sep 2010. 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?

Respiratory sounds recordings (time frame: 1 hour). 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 14 Sep 2010.

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