Cough Monitoring Study



Status:Completed
Conditions:Gastroesophageal Reflux Disease , Infectious Disease
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2010
End Date:October 2011
Contact:Tina Higginbotham, MPA
Email:tina.higginbotham@vanderbilt.edu
Phone:615-322-4643

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Monitoring Cough Device - Step 1 and 2


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.


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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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mi
from
Nashville, TN
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