Cough in Reduced True Vocal Fold Mobility

Unilateral Vocal Cord Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407301
• Other study ID #: IRB201400733
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: May 11, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Unilateral Vocal Cord Paralysis
• Unilateral Vocal Cord Paresis
• Vocal Cord Paralysis

Intervention

Other:
• cough airflow measure
Participants will produce multiple voluntary coughs for cough airflow assessment.
• vocal tasks
The assessment of glottal closure will be performed during phonation tasks.
• true vocal fold movement
The true vocal fold (TVF) movement in cough will be observed and recorded during cough production.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida ENT Clinic	Gainesville	Florida
United States	University of Florida Speech and Hearing Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak expiratory flow rate (PEFR)	Maximum flow rate in expiratory phase, expressed in liters per second (L/s)	baseline	No
Primary	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.	baseline	No
Primary	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.	baseline	No
Primary	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.	baseline	No
Primary	Peak expiratory flow rise time (PEFRT)	Time to reach peak expiratory flow rate expressed in seconds	baseline	No
Primary	Cough volume acceleration (CVA)	A ratio of peak expiratory flow rate and peak expiratory flow rise time expressed in L/s/s	baseline	No
Primary	Expiratory phase duration	Duration of expiratory phase of cough expressed in seconds	baseline	No
Secondary	Peak expiratory flow	Maximum flow rate during forced exhalation expressed in L/s	baseline	No
Secondary	Maximum expiratory pressure	Maximum expiratory pressure will be expressed in cmH2O.	baseline	No
Secondary	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).	baseline	No
Secondary	Forced vital capacity (FVC)	Maximum amount of air that can be exhaled with maximal speed and effort after maximum inhalation, expressed in L	baseline	No
Secondary	Forced expired volume within 1 second (FEV1)	Maximum amount of air exhaled forcefully within 1 second, expressed in L.	baseline	No
Secondary	The ratio FEV1/FVC	The percent (%) of forcefully exhaled air that can be exhaled during the first second of exhalation.	baseline	No