Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2015-04-30
2016-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. History of the adverse reaction associated with laryngoscopy.
40 Years
75 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Karen W Hegland, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida ENT Clinic
Gainesville, Florida, United States
University of Florida Speech and Hearing Center
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201400733
Identifier Type: -
Identifier Source: org_study_id
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