Accuracy of Cough Detection in Healthy Adults

This study has been completed.

Sponsor:

Information provided by:

KarmelSonix Ltd.

ClinicalTrials.gov Identifier:

NCT00907491

First received: May 21, 2009

Last updated: June 8, 2011

Last verified: May 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 21, 2009
Last Updated Date	June 8, 2011
Start Date ^ICMJE	February 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 21, 2009)	To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions [ Time Frame: within 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00907491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Accuracy of Cough Detection in Healthy Adults
Official Title ^ICMJE	Use of Objective Cough Counting Device to Assess the Accuracy of Cough Detection in Healthy Adults Simulating Cough in Different Postures, Mobility and Environmental Conditions
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Healthy adults 21 years and above
Condition ^ICMJE	Cough
Intervention ^ICMJE	Device: pulmonary sounds analyzer Cough counting device based on the WIM Technology
Study Group/Cohort (s)	A Intervention: Device: pulmonary sounds analyzer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	54
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient signed informed consent Patients above 21 years old No medical history Exclusion Criteria: Skin lesions precluding attachment of sensors Pregnancy
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00907491
Other Study ID Numbers ^ICMJE	WIM-CC 01
Has Data Monitoring Committee	No
Responsible Party	Dr. Hanna Levy - Director of clinical studies, KarmelSonix Ltd
Study Sponsor ^ICMJE	KarmelSonix Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	KarmelSonix Ltd.
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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