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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01263626
Other study ID # MCD 1-2
Secondary ID
Status Completed
Phase N/A
First received December 16, 2010
Last updated June 5, 2015
Start date November 2010
Est. completion date December 2014

Study information

Verified date June 2015
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.

Cough is an important defense mechanism of the respiratory tract. The presence of chronic cough may indicate the presence of underlying diseases, including reflux. Despite the increased number of patients suffering from cough in the ENT and GI practice, to date, there has been no method/device to objectively assess the frequency of cough episodes in a given patient.

PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an innovative device that is able to record cough episodes and then automatically detect and count them with the help of a specific software program. This study will assess the accuracy of this novel cough monitoring and counting technology and validate potential clinical use in patients with chronic cough.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 2014
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Arm 1: healthy volunteers:

1. Male and female volunteers 18 years of age and older

2. No history of chronic or acute cough and throat clearing

3. Ability to read a 5th grade script written in English for approximately 20 minutes

Arm 2: patients:

1. Male and female volunteers 18 years of age and older

2. Cough as chief complaint

3. Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint

4. pH testing for standard of care purposes

Exclusion Criteria:

- Subjects who are not able to give informed consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of Cough Device The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes. 24 hours post device placement No
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