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Cough in Reduced True Vocal Fold Mobility

Voluntary Cough Airflow Dynamics and True Vocal Fold Kinematics in Persons With Reduced True Vocal Fold Mobility

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02407301
Enrollment
15
Registered
2015-04-02
Start date
2015-04-30
Completion date
2016-02-29
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Vocal Cord Paresis, Unilateral Vocal Cord Paralysis

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.

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.

Interventions

OTHERcough airflow measure

Participants will produce multiple voluntary coughs for cough airflow assessment.

OTHERvocal tasks

The assessment of glottal closure will be performed during phonation tasks.

OTHERtrue vocal fold movement

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

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.

OTHERmaximum 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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Expiratory phase durationbaselineDuration of expiratory phase of cough expressed in seconds
Peak expiratory flow rate (PEFR)baselineMaximum flow rate in expiratory phase, expressed in liters per second (L/s)
True vocal fold maximum abduction angles in inspiratory phasebaselineThe TVF maximum abduction angles during cough inspiratory phase of cough will be expressed in degrees.
True vocal fold maximum abduction angles in expiratory phasebaselineTrue vocal fold maximum abduction angles in expiratory phase of cough will be expressed in degrees.
True vocal fold maximum adduction angles in compression phasebaselineTrue vocal fold maximum adduction angles in compression phase of cough will be expressed in degrees.
Peak expiratory flow rise time (PEFRT)baselineTime to reach peak expiratory flow rate expressed in seconds
Cough volume acceleration (CVA)baselineA ratio of peak expiratory flow rate and peak expiratory flow rise time expressed in L/s/s

Secondary

MeasureTime frameDescription
Maximum expiratory pressurebaselineMaximum expiratory pressure will be expressed in cmH2O.
Degree of glottal closurebaselineThe 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).
Forced vital capacity (FVC)baselineMaximum amount of air that can be exhaled with maximal speed and effort after maximum inhalation, expressed in L
Forced expired volume within 1 second (FEV1)baselineMaximum amount of air exhaled forcefully within 1 second, expressed in L.
The ratio FEV1/FVCbaselineThe percent (%) of forcefully exhaled air that can be exhaled during the first second of exhalation.
Peak expiratory flowbaselineMaximum flow rate during forced exhalation expressed in L/s

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026