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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00907491
Other study ID # WIM-CC 01
Secondary ID
Status Completed
Phase N/A
First received May 21, 2009
Last updated June 8, 2011
Start date February 2008
Est. completion date July 2009

Study information

Verified date May 2009
Source KarmelSonix Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

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.

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


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Patient signed informed consent

- Patients above 21 years old

- No medical history

Exclusion Criteria:

- Skin lesions precluding attachment of sensors

- Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Device:
pulmonary sounds analyzer
Cough counting device based on the WIM Technology

Locations

Country Name City State
Israel RAMBAM Health Care Campus Haifa,

Sponsors (1)

Lead Sponsor Collaborator
KarmelSonix Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions within 2 weeks No
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