Cough Monitoring Study

NCT01263626 | Completed

• 1 other identifier: MCD 1-2
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Cough; Chronic Cough; Reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Subjects who are not able to give informed consent

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 26492842 DERIVED

MeSH Terms

Conditions

Cough; Gastroesophageal Reflux; Chronic Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael Vaezi, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (1)