Cough Monitoring Study

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01263626

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cough Reflux

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Monitoring Cough Device - Step 1 and 2

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Cough as Primary Complaint Male and female volunteers 18 years of age and older Cough as chief complaint Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint pH testing for standard of care purposes
Healthy Volunteers Male and female volunteers 18 years of age and older No history of chronic or acute cough and throat clearing Ability to read a 5th grade script written in English for approximately 20 minutes

Outcome Measures

Primary Outcome Measures

Accuracy of Cough Device [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Arm 1: healthy volunteers:

Male and female volunteers 18 years of age and older
No history of chronic or acute cough and throat clearing
Ability to read a 5th grade script written in English for approximately 20 minutes

Arm 2: patients:

Male and female volunteers 18 years of age and older
Cough as chief complaint
Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint
pH testing for standard of care purposes

Exclusion Criteria:

Subjects who are not able to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Vaezi, Medical Director, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01263626

Other Study ID Numbers:

MCD 1-2

First Posted:

Dec 21, 2010

Last Update Posted:

Jun 8, 2015

Last Verified:

Jun 1, 2015

Keywords provided by Michael Vaezi, Medical Director, Vanderbilt University

Cough

Chronic Cough

Reflux

Additional relevant MeSH terms:

Cough

Study Results

No Results Posted as of Jun 8, 2015