Cough Monitoring Study

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.

Completed

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Key information

Conditions

Cough Chronic Cough Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Reflux Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Accuracy of Cough Device

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Monitoring Cough Device - Step 1 and 2

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2014
First posted: Dec 21, 2010
Registry last updated: Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed