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Cough in Reduced True Vocal Fold Mobility

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ClinicalTrials.gov Identifier: NCT02407301
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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. 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.

Condition or disease Intervention/treatment
Unilateral Vocal Cord Paresis Unilateral Vocal Cord Paralysis Other: cough airflow measure Other: vocal tasks Other: true vocal fold movement Other: spirometry test Other: maximum expiratory pressure (MEP)

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 Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voluntary Cough Airflow Dynamics and True Vocal Fold Kinematics in Persons With Reduced True Vocal Fold Mobility
Study Start Date : April 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Group/Cohort Intervention/treatment
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.
Other: cough airflow measure
Participants will produce multiple voluntary coughs for cough airflow assessment.
Other Name: cough airflow assessment

Other: vocal tasks
The assessment of glottal closure will be performed during phonation tasks.
Other Name: phonation tasks

Other: true vocal fold movement
The true vocal fold (TVF) movement in cough will be observed and recorded during cough production.
Other Name: TVF movement

Other: spirometry test
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.
Other Name: spirometry

Other: maximum expiratory pressure (MEP)
The assessment of maximum expiratory pressure will require forceful exhalations into a mouthpiece of a manometer during maximum expiratory pressure (MEP) assessment.
Other Name: MEP




Primary Outcome Measures :
  1. Peak expiratory flow rate (PEFR) [ Time Frame: baseline ]
    Maximum flow rate in expiratory phase, expressed in liters per second (L/s)

  2. 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.

  3. 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.

  4. 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.

  5. Peak expiratory flow rise time (PEFRT) [ Time Frame: baseline ]
    Time to reach peak expiratory flow rate expressed in seconds

  6. 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

  7. Expiratory phase duration [ Time Frame: baseline ]
    Duration of expiratory phase of cough expressed in seconds


Secondary Outcome Measures :
  1. Peak expiratory flow [ Time Frame: baseline ]
    Maximum flow rate during forced exhalation expressed in L/s

  2. Maximum expiratory pressure [ Time Frame: baseline ]
    Maximum expiratory pressure will be expressed in cmH2O.

  3. Degree of glottal closure [ Time Frame: baseline ]
    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).

  4. Forced vital capacity (FVC) [ Time Frame: baseline ]
    Maximum amount of air that can be exhaled with maximal speed and effort after maximum inhalation, expressed in L

  5. Forced expired volume within 1 second (FEV1) [ Time Frame: baseline ]
    Maximum amount of air exhaled forcefully within 1 second, expressed in L.

  6. The ratio FEV1/FVC [ Time Frame: baseline ]
    The percent (%) of forcefully exhaled air that can be exhaled during the first second of exhalation.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants will represent a population of patients with glottal insufficiency due to unilateral true vocal fold immobility.
Criteria

Inclusion Criteria:

  1. Age between 40 and 75 years.
  2. Glottal insufficiency secondary to reduced TVF mobility confirmed with the endoscopic evaluation performed by an otolaryngologist.
  3. The ability to provide informed consent.
  4. No history of chronic obstructive pulmonary disease, lung cancer, and/or lung transplant.
  5. 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.

Exclusion Criteria:

  1. Chest infection within one month prior to the study participation.
  2. History of the adverse reaction associated with laryngoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407301


Locations
United States, Florida
University of Florida ENT Clinic
Gainesville, Florida, United States, 32610
University of Florida Speech and Hearing Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Karen W Hegland, Ph.D. University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02407301     History of Changes
Other Study ID Numbers: IRB201400733
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Paralysis
Paresis
Vocal Cord Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases