Symptom Scoring for Predicting Vocal Cord Dysfunction (VCD)

Withdrawn

• Conditions: Vocal Cord Dysfunction

• Registration Number: NCT05114083
• Lead Sponsor: Ohio State University

Brief Summary

Dr. Russell Traister, et al, describes a symptom scoring system based on retrospective chart review to help identify subjects with VCD. Dr. Traister assigned the following symptom scores: dysphonia (2), throat tightness (4), sensitivity to odors (3) and absence of wheezing (2). Patients scoring 4 or more points have a positive predictive value of 96% and a negative predictive value of 77% for VCD. This prospective study will look at a population of patients presenting to a large tertiary care referral center for symptoms of cough. Patients seen at the "Cough Clinic" are evaluated by a Pulmonologist and an Otolaryngologist. Each patient undergoes pulmonary function testing and VLS testing as part of the diagnostic workup. For this study the history would be expanded to include the 4 specific symptoms: dysphonia, throat tightness, sensitivity to odors and absence of wheezing. The symptoms will be scored and compared against the results of diagnostic testing to determine if these symptoms help predict those with vocal cord dysfunction (VCD).

Detailed Description

Vocal cord dysfunction (VCD) refers to the abnormal adduction of the vocal cords during breathing resulting in extrathoracic airway obstruction. These patients often complain of wheezing, cough and shortness of breath. Symptoms of VCD mimic asthma often leading to misdiagnosis and exposure to unneeded medications. Speech therapy rather than medications is the mainstay of treatment for VCD.

The gold standard diagnostic tool for detection of VCD is direct visualization of the vocal cords using flexible video assisted fiberoptic laryngoscopy (VLS). VCD is present if the cords constrict greater than 50% during the respiratory cycle. VLS is well tolerated however it is an invasive procedure and costly. Identifying patients who most likely have VCD for VLS testing would reduce health related expense and avoid unnecessary procedures. Dr. Russell Traister, et al, describes a symptom scoring system based on retrospective chart review to help identify subjects with VCD. Dr. Traister assigned the following symptom scores: dysphonia (2), throat tightness (4), sensitivity to odors (3) and absence of wheezing (2). Patients scoring 4 or more points have a positive predictive value of 96% and a negative predictive value of 77% for VCD.

This prospective study will look at a population of patients presenting to a large tertiary care referral center for symptoms of cough. Currently patients seen at the "Cough Clinic" are evaluated by a pulmonologist and an Otolaryngologist during their visit. Each patient undergoes pulmonary function testing and VLS testing as part of the diagnostic workup. For this study the history would be expanded to include the 4 specific symptoms described above and scores tabulated and compared against the results of diagnostic testing. The findings of this study will help providers understand the characteristics of patients with VCD and use this information when deciding which patients should be referred for VLS testing.

Study Timeline

• Study First Submitted: 2015-09-24
• Study Start: 2017-01
• Status Verified: 2021-10
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All participants male and female,
• age 18 years and older
• presenting as new patients to the Cough Clinic

Exclusion Criteria

• Participants less than 18 years of age and those attended by a guardian or an interpreter

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine if symptom scoring can accurately predict vocal cord dysfunction	1 year	We will score each patient according to their symptoms of vocal cord dysfunction including; throat tightness (4 points), dysphonia (2 points), absence of wheezing (2 points), symptoms triggered by strong odors (3 points). A positive response will be assigned the score as indicated in parentheses behind each symptom. A negative response will be assigned zero points.