Accuracy of Cough Detection in Healthy Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Device: pulmonary sounds analyzer

• Study Type: Observational
• Enrollment (Anticipated): 54

Contacts and Locations

Study Locations

• Israel
  • Haifa,, Israel, 31096
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults 21 years and above

Description

Inclusion Criteria:

• Patient signed informed consent
• Patients above 21 years old
• No medical history

Exclusion Criteria:

• Skin lesions precluding attachment of sensors
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A	Device: pulmonary sounds analyzer; Cough counting device based on the WIM Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions	within 2 weeks

Collaborators and Investigators

• Sponsor: KarmelSonix Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): June 9, 2011
• Last Update Submitted That Met QC Criteria: June 8, 2011
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Cough; Wheeze Rate; Respiratory Function Tests
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: WIM-CC 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No