Cough Monitoring Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01263626
First received: December 16, 2010
Last updated: April 29, 2014
Last verified: December 2012

December 16, 2010
April 29, 2014
November 2010
January 2012   (final data collection date for primary outcome measure)
Accuracy of Cough Device [ Time Frame: 24 hours post device placement ] [ Designated as safety issue: No ]
The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.
Same as current
Complete list of historical versions of study NCT01263626 on ClinicalTrials.gov Archive Site
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Cough Monitoring Study
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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients who present to the ENT or GI clinics at Vanderbilt Medical Center with a chief complaint of chronic cough will be eligible for participation in this study. Patients who meet eligibility requirements will be able to participate regardless of sex, social status, or ethnicity.

  • Cough
  • Reflux
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  • Cough as Primary Complaint
    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
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
June 2014
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01263626
MCD 1-2
No
Michael Vaezi, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Michael Vaezi, MD, PhD Vanderbilt University
Vanderbilt University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP