Cough Count Validation

People with respiratory infection, asthmatic patients and cystic fibrosis (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 assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.

Study Overview

• Status: Unknown
• Conditions: Chronic Cough

Detailed Description

Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways . While the cough reflex is essential in protecting the lung from foreign materials and infection, its excessive or chronic presence is both bothersome and might interfere with the quality of life, sleep pattern and exercise tolerance of the patient. Such a symptom may potentially be indicative of an on-going pathological process , .

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 assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.

The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.

The PulmoTrack™ technology includes the PulmoTrack™ 3010/5050 devices that are intended for the analysis, interpretation and recording of lung sounds, and the Automatic Cough Counting Application.

The recording of the lung sounds will be performed by a PulmoTrack™ 3010/5050 device. The lung sounds can subsequently be analyzed for the presence of wheezes and for the presence of cough by the Automatic Cough Counting Application (ACCA).

The technology enables accurate cough count and timing as well as wheeze detection over time.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
    • Principal Investigator: Eitan Kerem, MD
    • Contact: Ezekiel balouka, BSc; Phone Number: 0523121098; Email: ezekiel@karmelsonix.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic cough

Description

Inclusion Criteria:

• Age 2-80 years.
• Patients with significant chronic cough.
• Patients in hemodynamic stability. Patient is not in respiratory distress.
• Subject or subject's parents/guardians is able to comprehend and give informed consent for participation in the study.

Exclusion Criteria:

• Contraindication to the use of the PulmoTrack™ or performing ARM (Acoustic Respiratory Monitoring).
• Hemodynamic instability and/or SOB.
• Concurrent additional major illness.
• Concurrent participation in any other study.
• Physician objection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient with chronic cough

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cough count	recording lasting up to 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
WheezeRate (the proportion of wheezing in the respiratory cycle) , respiratory rate, Inspiratory/Expiratory ratio, SPO2, symptom score (according to a questioner)	recording lasting up to 24 hours

Collaborators and Investigators

• Sponsor: KarmelSonix Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 9, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: KSI-IL-HHZ-CCF-01