Text Size

Cough Count Validation

This study is not yet open for participant recruitment.
Verified August 2011 by KarmelSonix Ltd.
Sponsor:
Information provided by:
KarmelSonix Ltd.
ClinicalTrials.gov Identifier:
NCT01413698
First received: August 9, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition
Chronic Cough

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Cough
U.S. FDA Resources

Further study details as provided by KarmelSonix Ltd.:

Primary Outcome Measures:
  • Cough count [ Time Frame: recording lasting up to 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • WheezeRate (the proportion of wheezing in the respiratory cycle) , respiratory rate, Inspiratory/Expiratory ratio, SPO2, symptom score (according to a questioner) [ Time Frame: recording lasting up to 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient with 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.

  Eligibility

Ages Eligible for Study:   2 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic cough

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413698

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Ezekiel balouka, BSc     0523121098     ezekiel@karmelsonix.com    
Principal Investigator: Eitan Kerem, MD            
Sponsors and Collaborators
KarmelSonix Ltd.
  More Information

No publications provided

Responsible Party: Prof. Noam Gavriely MD, PhD., KarmelSonix Ltd.
ClinicalTrials.gov Identifier: NCT01413698     History of Changes
Other Study ID Numbers: KSI-IL-HHZ-CCF-01
Study First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013