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Cough Monitoring Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263626
First Posted: December 21, 2010
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
  Purpose

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.


Condition
Cough Reflux

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Monitoring Cough Device - Step 1 and 2

Resource links provided by NLM:


Further study details as provided by Michael Vaezi, Vanderbilt University:

Primary Outcome Measures:
  • Accuracy of Cough Device [ Time Frame: 24 hours post device placement ]
    The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.


Enrollment: 33
Study Start Date: November 2010
Study Completion Date: December 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263626


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael Vaezi, MD, PhD Vanderbilt University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01263626     History of Changes
Other Study ID Numbers: MCD 1-2
First Submitted: December 16, 2010
First Posted: December 21, 2010
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Michael Vaezi, Vanderbilt University:
Cough
Chronic Cough
Reflux

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms


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