CompletedNot Applicable

Cough in Reduced True Vocal Fold Mobility

United States15 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak expiratory flow rate (PEFR)

Timeframe: baseline

True vocal fold maximum abduction angles in inspiratory phase

Timeframe: baseline

True vocal fold maximum abduction angles in expiratory phase

Timeframe: baseline

True vocal fold maximum adduction angles in compression phase

Timeframe: baseline

Peak expiratory flow rise time (PEFRT)

Timeframe: baseline

Cough volume acceleration (CVA)

Timeframe: baseline

Expiratory phase duration

Timeframe: baseline

Trial details

NCT IDNCT02407301

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Unilateral Vocal Cord Paresis trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Peak expiratory flow rate (PEFR)

Timeframe: baseline

True vocal fold maximum abduction angles in inspiratory phase

Timeframe: baseline

True vocal fold maximum abduction angles in expiratory phase

Timeframe: baseline

True vocal fold maximum adduction angles in compression phase

Timeframe: baseline

Peak expiratory flow rise time (PEFRT)

Timeframe: baseline

Cough volume acceleration (CVA)

Timeframe: baseline

Expiratory phase duration

Timeframe: baseline