Unilateral Vocal Cord ParesisNCT02407301
Cough in Reduced True Vocal Fold Mobility
An observational study of Unilateral Vocal Cord Paresis and Unilateral Vocal Cord Paralysis, run by University of Florida at 2 sites in United States.
Trial summary
This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF) adduction and abduction angles during voluntary cough to examine the effects of changes in glottal closure due to reduced mobility of one true vocal fold. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Unilateral Vocal Cord Paresis, Unilateral Vocal Cord Paralysis
- What is being tested?
- cough airflow measure, vocal tasks and true vocal fold movement
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Feb 2016
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will represent a population of patients with glottal insufficiency due to unilateral true vocal fold immobility.
Who may be able to join
- Age between 40 and 75 years.
- Glottal insufficiency secondary to reduced TVF mobility confirmed with the endoscopic evaluation performed by an otolaryngologist.
- The ability to provide informed consent.
- No history of chronic obstructive pulmonary disease, lung cancer, and/or lung transplant.
- No history of neurodegenerative disease such as Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or progressive supranuclear palsy (PSP), Alzheimer's disease, or dementia.
Who cannot join
- Chest infection within one month prior to the study participation.
- History of the adverse reaction associated with laryngoscopy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida ENT Clinic
Gainesville, Florida, 32610
University of Florida Speech and Hearing Center
Gainesville, Florida, 32610
About this study
Official title: Voluntary Cough Airflow Dynamics and True Vocal Fold Kinematics in Persons With Reduced True Vocal Fold Mobility
This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF) adduction and abduction angles during voluntary cough to examine the effects of changes in glottal closure due to reduced mobility of one true vocal fold. The hypothesis of this study is that the incomplete glottal closure due to reduced vocal fold mobility will result in changes in true vocal fold adductory and abductory angles during cough and will result in changes to voluntary cough airflow parameters. This study results will contribute to the existing knowledge of the laryngeal contribution to cough airflow dynamics.
Read the detailed description
The study investigators will consecutively recruit 30 adults diagnosed with vocal fold insufficiency due to reduced mobility of one true vocal fold.
A questionnaire will be used to collect participants' information. Demographic information such as age, gender, race/ethnicity, height, weight, and a major complaint (dysphonia and/or dysphagia) and medical history information determining the eligibility for participation will be collected from the participant. Participant's medical and surgical history specifically related to the diagnosis and the etiology of reduced vocal fold mobility will be obtained from the participant's medical record.
Videolaryngoscopy will be performed as part of standard clinical care. Vocal fold image and cough airflow will be recorded simultaneously during voluntary cough production with the flexible endoscope in nasopharynx. A second part of the study will include spirometry and expiratory muscle strength assessments. Video images of the vocal fold movement during vowel phonation and cough production will be recorded and stored on a CD for later analysis. The cough airflow recordings will be displayed, stored, and analyzed using LabChart software for Windows.
- Being tested
- cough airflow measure, vocal tasks, true vocal fold movement, spirometry test, maximum expiratory pressure (MEP)
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cough airflow measureOther
Also called cough airflow assessment
Participants will produce multiple voluntary coughs for cough airflow assessment.
vocal tasksOther
Also called phonation tasks
The assessment of glottal closure will be performed during phonation tasks.
true vocal fold movementOther
Also called TVF movement
The true vocal fold (TVF) movement in cough will be observed and recorded during cough production.
spirometry testOther
Also called spirometry
The lung function test will require the participant to perform deep inhalations and forceful exhalations into the flow head of the spirometer during spirometry test.
maximum expiratory pressure (MEP)Other
Also called MEP
The assessment of maximum expiratory pressure will require forceful exhalations into a mouthpiece of a manometer during maximum expiratory pressure (MEP) assessment.
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal function in cough | cough airflow measure, vocal tasks, true vocal fold movement, spirometry test, and maximum expiratory pressure (MEP) assessment will be performed in this group. Receives: Other: cough airflow measure; Other: vocal tasks; Other: true vocal fold movement; Other: spirometry test; Other: maximum expiratory pressure (MEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow rate (PEFR)
Maximum flow rate in expiratory phase, expressed in liters per second (L/s)
Measured: baseline
True vocal fold maximum abduction angles in inspiratory phase
The TVF maximum abduction angles during cough inspiratory phase of cough will be expressed in degrees.
Measured: baseline
True vocal fold maximum abduction angles in expiratory phase
True vocal fold maximum abduction angles in expiratory phase of cough will be expressed in degrees.
Measured: baseline
True vocal fold maximum adduction angles in compression phase
True vocal fold maximum adduction angles in compression phase of cough will be expressed in degrees.
Measured: baseline
Peak expiratory flow rise time (PEFRT)
Time to reach peak expiratory flow rate expressed in seconds
Measured: baseline
Cough volume acceleration (CVA)
A ratio of peak expiratory flow rate and peak expiratory flow rise time expressed in L/s/s
Measured: baseline
Expiratory phase duration
Duration of expiratory phase of cough expressed in seconds
Measured: baseline
Secondary outcomes (6)
Peak expiratory flow
Maximum flow rate during forced exhalation expressed in L/s
Measured: baseline
Maximum expiratory pressure
Maximum expiratory pressure will be expressed in cmH2O.
Measured: baseline
Degree of glottal closure
The degree of glottal closure will be assessed during phonation using glottic closure rating scale 1-6, 1=complete closure, 6=incomplete closure all along the vocal folds (Södersten et al., 1990).
Measured: baseline
Forced vital capacity (FVC)
Maximum amount of air that can be exhaled with maximal speed and effort after maximum inhalation, expressed in L
Measured: baseline
Forced expired volume within 1 second (FEV1)
Maximum amount of air exhaled forcefully within 1 second, expressed in L.
Measured: baseline
The ratio FEV1/FVC
The percent (%) of forcefully exhaled air that can be exhaled during the first second of exhalation.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Vocal Cord ParesisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen W Hegland, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407301
- Sponsor's protocol ID
- IRB201400733
- Status last verified
- May 2016
- First submitted
- 30 Mar 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntary Cough Airflow Dynamics and True Vocal Fold Kinematics in Persons With Reduced True Vocal Fold Mobility
- ClinicalTrials.gov ID
- NCT02407301
- Acronym / sponsor ID
- IRB201400733
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Apr 2015 (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.
This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF) adduction and abduction angles during voluntary cough to examine the effects of changes in glottal closure due to reduced mobility of one true vocal fold. The hypothesis of this study is that the incomplete glottal closure due to reduced vocal fold mobility will result in changes in true vocal fold adductory and abductory angles during cough and will result in changes to voluntary cough airflow parameters. This study results will contribute to the existing knowledge of the laryngeal contribution to cough airflow dynamics.
Detailed description
The study investigators will consecutively recruit 30 adults diagnosed with vocal fold insufficiency due to reduced mobility of one true vocal fold.
A questionnaire will be used to collect participants' information. Demographic information such as age, gender, race/ethnicity, height, weight, and a major complaint (dysphonia and/or dysphagia) and medical history information determining the eligibility for participation will be collected from the participant. Participant's medical and surgical history specifically related to the diagnosis and the etiology of reduced vocal fold mobility will be obtained from the participant's medical record.
Videolaryngoscopy will be performed as part of standard clinical care. Vocal fold image and cough airflow will be recorded simultaneously during voluntary cough production with the flexible endoscope in nasopharynx. A second part of the study will include spirometry and expiratory muscle strength assessments. Video images of the vocal fold movement during vowel phonation and cough production will be recorded and stored on a CD for later analysis. The cough airflow recordings will be displayed, stored, and analyzed using LabChart software for Windows.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngeal function in cough | – | Other: cough airflow measure, Other: vocal tasks, Other: true vocal fold movement, Other: spirometry test, Other: maximum expiratory pressure (MEP)cough airflow measure, vocal tasks, true vocal fold movement, spirometry test, and maximum expiratory pressure (MEP) assessment will be performed in this group. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will represent a population of patients with glottal insufficiency due to unilateral true vocal fold immobility.
Key inclusion criteria (5 listed)
- Age between 40 and 75 years.
- Glottal insufficiency secondary to reduced TVF mobility confirmed with the endoscopic evaluation performed by an otolaryngologist.
- The ability to provide informed consent.
- No history of chronic obstructive pulmonary disease, lung cancer, and/or lung transplant.
- No history of neurodegenerative disease such as Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or progressive supranuclear palsy (PSP), Alzheimer's disease, or dementia.
Key exclusion criteria (2 listed)
- Chest infection within one month prior to the study participation.
- History of the adverse reaction associated with laryngoscopy.
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 |
|---|---|---|
| cough airflow measureAlso: cough airflow assessmentParticipants will produce multiple voluntary coughs for cough airflow assessment. | Other | Laryngeal function in cough |
| vocal tasksAlso: phonation tasksThe assessment of glottal closure will be performed during phonation tasks. | Other | Laryngeal function in cough |
| true vocal fold movementAlso: TVF movementThe true vocal fold (TVF) movement in cough will be observed and recorded during cough production. | Other | Laryngeal function in cough |
| spirometry testAlso: spirometryThe lung function test will require the participant to perform deep inhalations and forceful exhalations into the flow head of the spirometer during spirometry test. | Other | Laryngeal function in cough |
| maximum expiratory pressure (MEP)Also: MEPThe assessment of maximum expiratory pressure will require forceful exhalations into a mouthpiece of a manometer during maximum expiratory pressure (MEP) assessment. | Other | Laryngeal function in cough |
Primary outcome
Peak expiratory flow rate (PEFR)
Time frame: baseline
Maximum flow rate in expiratory phase, expressed in liters per second (L/s)
True vocal fold maximum abduction angles in inspiratory phase
Time frame: baseline
The TVF maximum abduction angles during cough inspiratory phase of cough will be expressed in degrees.
True vocal fold maximum abduction angles in expiratory phase
Time frame: baseline
True vocal fold maximum abduction angles in expiratory phase of cough will be expressed in degrees.
True vocal fold maximum adduction angles in compression phase
Time frame: baseline
True vocal fold maximum adduction angles in compression phase of cough will be expressed in degrees.
Peak expiratory flow rise time (PEFRT)
Time frame: baseline
Time to reach peak expiratory flow rate expressed in seconds
Cough volume acceleration (CVA)
Time frame: baseline
A ratio of peak expiratory flow rate and peak expiratory flow rise time expressed in L/s/s
Expiratory phase duration
Time frame: baseline
Duration of expiratory phase of cough expressed in seconds
6 secondary outcomes
Peak expiratory flow
Time frame: baseline
Maximum expiratory pressure
Time frame: baseline
Degree of glottal closure
Time frame: baseline
Forced vital capacity (FVC)
Time frame: baseline
Forced expired volume within 1 second (FEV1)
Time frame: baseline
The ratio FEV1/FVC
Time frame: baseline
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 13 May 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Unilateral Vocal Cord Paresis
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
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.
Karen W Hegland, Ph.D. principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Vocal Cord Paresis and Unilateral Vocal Cord Paralysis, run by University of Florida at 2 sites 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 5 inclusion and 2 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Peak expiratory flow rate (PEFR) (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.