Cough in Reduced True Vocal Fold Mobility

NCT02407301 | Completed

• 1 other identifier: IRB201400733
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Unilateral Vocal Cord Paresis; Unilateral Vocal Cord Paralysis

Outcome Measures

Primary Outcomes (7)

• Peak expiratory flow rate (PEFR)

  Maximum flow rate in expiratory phase, expressed in liters per second (L/s)

  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.

  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.

  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.

  baseline

• Peak expiratory flow rise time (PEFRT)

  Time to reach peak expiratory flow rate expressed in seconds

  baseline

• Cough volume acceleration (CVA)

  A ratio of peak expiratory flow rate and peak expiratory flow rise time expressed in L/s/s

  baseline

• Expiratory phase duration

  Duration of expiratory phase of cough expressed in seconds

  baseline

Secondary Outcomes (6)

• Peak expiratory flow

  baseline

• Maximum expiratory pressure

  baseline

• Degree of glottal closure

  baseline

• Forced vital capacity (FVC)

  baseline

• Forced expired volume within 1 second (FEV1)

  baseline

Study Arms (1)

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; Other: vocal tasks; Other: true vocal fold movement; Other: spirometry test; Other: maximum expiratory pressure (MEP)

Interventions

cough airflow measure OTHER

Participants will produce multiple voluntary coughs for cough airflow assessment.

Also known as: cough airflow assessment

Laryngeal function in cough

vocal tasks OTHER

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

Also known as: phonation tasks

Laryngeal function in cough

true vocal fold movement OTHER

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

Also known as: TVF movement

Laryngeal function in cough

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.

Also known as: spirometry

Laryngeal function in cough

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.

Also known as: MEP

Laryngeal function in cough

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

University of Florida ENT Clinic

Gainesville, Florida, 32610, United States

Location

University of Florida Speech and Hearing Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen W Hegland, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (2)