Cough Monitoring Study

Cough Clinical Trial

Official title:

Monitoring Cough Device - Step 1 and 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263626
• Other study ID #: MCD 1-2
• Status: Completed
• Phase: N/A
• First received: December 16, 2010
• Last updated: June 5, 2015
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cough
• Reflux

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Cough Device	The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.	24 hours post device placement	No