Cough Monitoring Study

Monitoring Cough Device - Step 1 and 2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01263626

Enrollment

Registered

2010-12-21

Start date

2010-11-30

Completion date

2014-12-31

Last updated

2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Reflux

Keywords

Cough, Chronic Cough, Reflux

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results