Clinical trial NCT01413698: Cough Count Validation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Cough
Lead sponsor: KarmelSonix Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic cough

Brief summary: 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.

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 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

Primary outcomes:
measure: Cough count
timeFrame: recording lasting up to 24 hours
Secondary outcomes:
measure: WheezeRate (the proportion of wheezing in the respiratory cycle) , respiratory rate, Inspiratory/Expiratory ratio, SPO2, symptom score (according to a questioner)
timeFrame: recording lasting up to 24 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: