Vocal Cord DysfunctionNCT05114083
Symptom Scoring for Predicting Vocal Cord Dysfunction (VCD)
An observational study of Vocal Cord Dysfunction, run by Ohio State University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Cord Dysfunction
- What is being tested?
- symptom assessment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All participants male and female, age 18 years and older presenting as new patients to the Cough Clinic will be asked to participate if they are not attended by a guardian or an interpreter. Everyone (regardless if they choose to participate or not) will receive current standard practice/care of the Cough Clinic for evaluation, testing and treatment.
Who may be able to join
- All participants male and female,
- age 18 years and older
- presenting as new patients to the Cough Clinic
Who cannot join
- Participants less than 18 years of age and those attended by a guardian or an interpreter
About this study
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).
Read the 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.
- Conditions
- Vocal Cord Dysfunction
- Being tested
- symptom assessment
- Medical subject headings
- Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptom assessmentOther
symptom assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if symptom scoring can accurately predict vocal cord dysfunction
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study startJan 2017
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: personnel redeployment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vocal Cord DysfunctionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Parsons, Ohio State University
- Investigators
- Jonathan Parsons, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114083
- Sponsor's protocol ID
- 2014H0368
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2015
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Parsons JP, Benninger C, Hawley MP, Philips G, Forrest LA, Mastronarde JG. Vocal cord dysfunction: beyond severe asthma. Respir Med. 2010 Apr;104(4):504-9. doi: 10.1016/j.rmed.2009.11.004. Epub 2009 Dec 4.
PubMed 19962874Wilson JJ, Theis SM, Wilson EM. Evaluation and management of vocal cord dysfunction in the athlete. Curr Sports Med Rep. 2009 Mar-Apr;8(2):65-70. doi: 10.1249/JSR.0b013e31819def3d.
PubMed 19276905Sterner JB, Morris MJ, Sill JM, Hayes JA. Inspiratory flow-volume curve evaluation for detecting upper airway disease. Respir Care. 2009 Apr;54(4):461-6.
PubMed 19327180Benninger C, Parsons JP, Mastronarde JG. Vocal cord dysfunction and asthma. Curr Opin Pulm Med. 2011 Jan;17(1):45-9. doi: 10.1097/MCP.0b013e32834130ee.
PubMed 21330824Traister RS, Fajt ML, Landsittel D, Petrov AA. A novel scoring system to distinguish vocal cord dysfunction from asthma. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):65-9. doi: 10.1016/j.jaip.2013.09.002. Epub 2013 Nov 2.
PubMed 24565771
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Scoring for Predicting Vocal Cord Dysfunction (VCD)
- ClinicalTrials.gov ID
- NCT05114083
- Acronym / sponsor ID
- 2014H0368
- Conditions
- Vocal Cord Dysfunction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: personnel redeployment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Nov 2021 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants male and female, age 18 years and older presenting as new patients to the Cough Clinic will be asked to participate if they are not attended by a guardian or an interpreter. Everyone (regardless if they choose to participate or not) will receive current standard practice/care of the Cough Clinic for evaluation, testing and treatment.
Key inclusion criteria (3 listed)
- All participants male and female,
- age 18 years and older
- presenting as new patients to the Cough Clinic
Key exclusion criteria (1 listed)
- Participants less than 18 years of age and those attended by a guardian or an interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| symptom assessmentsymptom assessment | Other | – |
Primary outcome
Determine if symptom scoring can accurately predict vocal cord dysfunction
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Background: PubMed 19962874Parsons JP, Benninger C, Hawley MP, Philips G, Forrest LA, Mastronarde JG. Vocal cord dysfunction: beyond severe asthma. Respir Med. 2010 Apr;104(4):504-9. doi: 10.1016/j.rmed.2009.11.004. Epub 2009 Dec 4.
- Background: PubMed 19276905Wilson JJ, Theis SM, Wilson EM. Evaluation and management of vocal cord dysfunction in the athlete. Curr Sports Med Rep. 2009 Mar-Apr;8(2):65-70. doi: 10.1249/JSR.0b013e31819def3d.
- Background: PubMed 19327180Sterner JB, Morris MJ, Sill JM, Hayes JA. Inspiratory flow-volume curve evaluation for detecting upper airway disease. Respir Care. 2009 Apr;54(4):461-6.
- Background: PubMed 21330824Benninger C, Parsons JP, Mastronarde JG. Vocal cord dysfunction and asthma. Curr Opin Pulm Med. 2011 Jan;17(1):45-9. doi: 10.1097/MCP.0b013e32834130ee.
- Background: PubMed 24565771Traister RS, Fajt ML, Landsittel D, Petrov AA. A novel scoring system to distinguish vocal cord dysfunction from asthma. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):65-9. doi: 10.1016/j.jaip.2013.09.002. Epub 2013 Nov 2.
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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.
Jonathan Parsons, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Cord Dysfunction, run by Ohio State University.
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 3 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: withdrawn, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determine if symptom scoring can accurately predict vocal cord dysfunction (time frame: 1 year). 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 NCT05114083, which also lists 5 linked publications.
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 9 Nov 2021.