- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184377
The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis
The Function of Cricothyroid Muscle and Its Impaction on Mandarin Lexical Tones in Unilateral Vocal Fold Paralysis: a Quantified Laryngeal Electromyography Based Research
Study Overview
Status
Conditions
Detailed Description
Purposes: 1. Searching for a standard task to measure CT function by Q-LEMG. 2. Correlate the data among Q-LEMG activity of CT muscle, lexical tone in Mandarin and vocal cord position and its impaction on vocal functions. 3. Detect the influence of lexical tone from conventional laryngoplasty for peripheral UVFP with eSLN injury.
Study designs: The current research is a two-year study. In the first year, the investigators will develop a standardized task for quantified LEMG analysis for CT muscles which were controlled by eSLN. In the second year, patients with acute UVFP will be enrolled into the study. By comprehensive evaluation including Q-LEMG analysis, the impact of injection laryngoplasty on tone adjustment can be identified. The results between UVFP with or without CT muscle damage will also be compared.
Predictive outcomes: 1. Developing a standard tool, Q-LEMG, to measure the function CT muscles. 2. Achieve the correlation of the neuromuscular control of lexical tone and CT muscle. 3. Analyze the impaction of early temporary injection on speech modal tone in Mandarin speakers and neuromuscular control in CT muscles. 4. Applying the data of tone and CT signals to future pitch controlled artificial electrolarynx animal models.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Linkuo, Taiwan
- Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with acute unilateral vocal palsy
- Patients with clear conscious and stable mental status
Exclusion Criteria:
- Patients with wounds on the neck or with bleeding disorder or serious cardiopulmonary dysfunction
- Patients who cannot sit for longer than 30 minutes or received other vocal cord treatments before the selection
- Pregnant and breastfeeding women
- Patients with communication disorder
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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RLN+SLN paralysis
unilateral recurrent laryngeal and superior laryngeal nerve paralysis
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RLN paralysis
unilateral recurrent laryngeal nerve paralysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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laryngeal electromyography
Time Frame: before hyaluronate injection; one month after hyaluronate injection
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before hyaluronate injection; one month after hyaluronate injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
laboratory voice analysis
Time Frame: before hyaluronate injection; one month after hyaluronate injection
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The voice analysis: fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) . |
before hyaluronate injection; one month after hyaluronate injection
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voice outcomes survey (VOS)
Time Frame: before hyaluronate injection; one month after hyaluronate injection
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questionnaire
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before hyaluronate injection; one month after hyaluronate injection
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Short form -36
Time Frame: before hyaluronate injection; one month after hyaluronate injection
|
questionnaire
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before hyaluronate injection; one month after hyaluronate injection
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voice range profile
Time Frame: before hyaluronate injection; one month after hyaluronate injection
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The voice will be analyzed by computerized software.
The extreme lowest and highest notes of frequencies production and the amplitude will be recorded and a voice map will be made as a plot of sound pressure level versus F0.
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before hyaluronate injection; one month after hyaluronate injection
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101_4920A3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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