Cough Monitoring Study

NCT ID: NCT01263626

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Cough; Reflux

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Vaezi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26492842 (View on PubMed)

Other Identifiers

MCD 1-2

Identifier Type: -

Identifier Source: org_study_id