Assessment of Cough and Wheeze With Breath Sound Documenting Device

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Sounds
• Intervention / Treatment: Device: PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; Study group	Device: PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies; wheeze and cough detection in hospitalized patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory sounds recordings	1 hour

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Study Chair: Yulia Goryachev, BSc, KarmelSonix Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 18, 2008
• First Submitted That Met QC Criteria: July 6, 2008
• First Posted (Estimate): July 8, 2008

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 13, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Cough; Respiratory sounds; Wheeze
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: CMC 07-0063