CoughNCT01263626
Cough Monitoring Study
An observational study of Cough and Reflux, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who present to the ENT or GI clinics at Vanderbilt Medical Center with a chief complaint of chronic cough will be eligible for participation in this study. Patients who meet eligibility requirements will be able to participate regardless of sex, social status, or ethnicity.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Subjects who are not able to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Monitoring Cough Device - Step 1 and 2
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.
- Keywords
- Cough, Chronic Cough, Reflux
- Medical subject headings
- Cough, Gastroesophageal Reflux, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cough as Primary Complaint | 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 | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post device placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University
- Investigators
- Michael Vaezi, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263626
- Sponsor's protocol ID
- MCD 1-2
- Status last verified
- Jun 2015
- First submitted
- 16 Dec 2010
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Francis DO, Slaughter JC, Ates F, Higginbotham T, Stevens KL, Garrett CG, Vaezi MF. Airway Hypersensitivity, Reflux, and Phonation Contribute to Chronic Cough. Clin Gastroenterol Hepatol. 2016 Mar;14(3):378-84. doi: 10.1016/j.cgh.2015.10.009. Epub 2015 Oct 19.
PubMed 26492842
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Cough Device - Step 1 and 2
- ClinicalTrials.gov ID
- NCT01263626
- Acronym / sponsor ID
- MCD 1-2
- Keywords
- Cough, Chronic Cough, Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cough as Primary Complaint | – | –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 | – | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the ENT or GI clinics at Vanderbilt Medical Center with a chief complaint of chronic cough will be eligible for participation in this study. Patients who meet eligibility requirements will be able to participate regardless of sex, social status, or ethnicity.
Key inclusion criteria (9 listed)
- 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
- Male and female volunteers 18 years of age and older
- Cough as chief complaint
Key exclusion criteria (1 listed)
- Subjects who are not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Derived from this study: PubMed 26492842Francis DO, Slaughter JC, Ates F, Higginbotham T, Stevens KL, Garrett CG, Vaezi MF. Airway Hypersensitivity, Reflux, and Phonation Contribute to Chronic Cough. Clin Gastroenterol Hepatol. 2016 Mar;14(3):378-84. doi: 10.1016/j.cgh.2015.10.009. Epub 2015 Oct 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Vaezi, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Reflux, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Cough Device (time frame: 24 hours post device placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.