Cough Clinical Trial
Official title:
Monitoring Cough Device - Step 1 and 2
Verified date | June 2015 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
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 |
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