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Completed

NCT Number: NCT02407301

Cough in 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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida ENT Clinic, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

cough airflow measure

Other

Participants will produce multiple voluntary coughs for cough airflow assessment.

Other names: cough airflow assessment

vocal tasks

Other

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

Other names: phonation tasks

true vocal fold movement

Other

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

Other names: TVF movement

spirometry test

Other

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 names: spirometry

maximum expiratory pressure (MEP)

Other

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

Other names: MEP

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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