Assessment of Cough and Wheeze With Breath Sound Documenting Device
Condition: Respiratory Sounds
MeSH terms: Respiratory Sounds
Study type: Observational

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.
    

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.
    

Intervention name(s): PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies
Intervention type(s): Device
Intervention description(s): wheeze and cough detection in hospitalized patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.
      
Keywords: Respiratory sounds; Wheeze; Cough