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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: December 19, 2012
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Cough GERD
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: November 2010
Estimated Study Completion Date: January 2013
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01263626     History of Changes
Other Study ID Numbers: MCD 1-2
Study First Received: December 16, 2010
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Cough
Chronic Cough
Reflux

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

ClinicalTrials.gov processed this record on May 16, 2013