Clinical trial NCT00711399: Assessment of Cough and Wheeze With Breath Sound Documenting Device
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Sounds
Keywords: Respiratory sounds
Wheeze
Cough
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2008-07-08
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory sounds recordings
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: KarmelSonix Ltd.
name: Yulia Goryachev, BSc
role: STUDY_CHAIR
References: