Cough Monitoring Study

Completed

• Conditions: Cough; Reflux

• Registration Number: NCT01263626
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Primary Completion: 2012-01
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-05
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States