Clinical Trials Directory

Trials / Completed

CompletedNCT02407301

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
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
University of Florida · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERcough airflow measureParticipants will produce multiple voluntary coughs for cough airflow assessment.
OTHERvocal tasksThe assessment of glottal closure will be performed during phonation tasks.
OTHERtrue vocal fold movementThe true vocal fold (TVF) movement in cough will be observed and recorded during cough production.
OTHERspirometry testThe 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.

Timeline

Start date
2015-04-01
Primary completion
2016-02-01
Completion
2016-02-01
First posted
2015-04-02
Last updated
2016-05-13

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02407301. Inclusion in this directory is not an endorsement.