Cough Monitoring Study

Vanderbilt University

Status: Completed

Conditions: Cough; Reflux

Study type: Observational

Funder types: Other

Identifiers

NCT01263626

MCD 1-2

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33 participants in 2 patient groups

Cough as Primary Complaint

Description:

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

Description:

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