Unilateral Vocal Cord ParalysisNCT02243722
Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
An observational study of Unilateral Vocal Cord Paralysis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance, which often happens after the treatment for laryngopharyngeal and esophageal cancer and may induce fatal complications such as aspiration pneumonia. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Unilateral Vocal Cord Paralysis
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to Nov 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from a tertian referral medical center.
Who may be able to join
- Patients with laryngopharyngeal or esophageal cancer who have taken active therapy and are not neck tissue damage.
- Patients with clear conscious and stable mental status
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tuan-Jen Fang, MD contact
About this study
Official title: Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance, which often happens after the treatment for laryngopharyngeal and esophageal cancer and may induce fatal complications such as aspiration pneumonia. By the conventional examinations, the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It is utmost important to establish a comprehensive quantitative method which is sensitive enough to evaluate the neuromuscular functions. The present project will evaluate the laryngeal nerve function by quantitative laryngeal electromyography, which was developed by the research team, and another novel examination technique, mucosal membrane sensation test. The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively before the significant symptoms or complications and can also help to evaluate the treatment effect from medicine, rehabilitation or surgery.
- Conditions
- Unilateral Vocal Cord Paralysis
- Keywords
- laryngeal electromyography, intrinsic laryngeal muscles, recurrent laryngeal nerve, superior laryngeal nerve, laryngeal sensation, tone language
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Larynx pharynx and Esophagus Ca with VCP | The cases of laryngopharyngeal and esophageal cancer with endoscopic characters of vocal fold motion impairment (paralysis or fixation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiberoptic endoscopic evaluation of swallowing (FEES)
Swallowing evaluation
Measured: Baseline:Within 3-6 months after synptom occurs
Laryngo-pharyngeal mucosa sensation test
There were four probes of different diameters that similar to the Von Frey filament were prepared for the examination. The diameters were 0.07mm, 0.15mm.0.2 mm and 0.3 mm. The mono-filament nylon probe was placed and contact with the tip and arytenoid mucosa.
Measured: Baseline:Within 3-6 months after synptom occurs
Secondary outcomes (5)
laryngeal electromyography
Measured: Baseline:Within 3-6 months after synptom occurs
laboratory voice analysis
fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .
Measured: Baseline:Within 3-6 months after synptom occurs
voice range profile
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.
Measured: Baseline:Within 3-6 months after synptom occurs
Voice Handicap Index (VHI)
Voice-related questionnaire The Voice Handicap Index (VHI) is a 30-item instrument developed by Jacobson et al. as a self-measure the psychosocial handicapping effects of voice disorders. The questionnaire consists of three sub scales: emotional, physical and functional with 10 items from each scale. It has been translated into traditional Chinese and validated. All individuals will be asked to response for the questionnaire.
Measured: Baseline:Within 3-6 months after synptom occurs
Disease related life quality assessment: FACT-H&N, FACT-E
Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N) and FACT-E (esophagus) are self -report questionnaires with a Likert-type response set, ranging from "not at all" to "very much". FACT-G (general) is a 27-items scale measures four QOL (quality of life) domains including Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. In FACT-H\&N, there are 11 additional specific questions for head and neck cancers while 17 additional items for esophageal cancers in FACT-E. The specific questionnaires will be provided to patients according to individual diseases. The traditional Chinese (Mandarin) version has been validated and proved to be useful in previous report. We have received the licensing agreement from the institute (FACIT) for using the questionnaires on the project.
Measured: Baseline:Within 3-6 months after synptom occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuan-Jen Fang, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243722
- Sponsor's protocol ID
- 102-5333A3
- Status last verified
- Feb 2014
- First submitted
- 16 Sep 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
- ClinicalTrials.gov ID
- NCT02243722
- Acronym / sponsor ID
- 102-5333A3
- Conditions
- Unilateral Vocal Cord Paralysis
- Keywords
- laryngeal electromyography, intrinsic laryngeal muscles, recurrent laryngeal nerve, superior laryngeal nerve, laryngeal sensation, tone language
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance, which often happens after the treatment for laryngopharyngeal and esophageal cancer and may induce fatal complications such as aspiration pneumonia. By the conventional examinations, the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It is utmost important to establish a comprehensive quantitative method which is sensitive enough to evaluate the neuromuscular functions. The present project will evaluate the laryngeal nerve function by quantitative laryngeal electromyography, which was developed by the research team, and another novel examination technique, mucosal membrane sensation test. The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively before the significant symptoms or complications and can also help to evaluate the treatment effect from medicine, rehabilitation or surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Larynx pharynx and Esophagus Ca with VCP | – | –The cases of laryngopharyngeal and esophageal cancer with endoscopic characters of vocal fold motion impairment (paralysis or fixation) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from a tertian referral medical center.
Key inclusion criteria (2 listed)
- Patients with laryngopharyngeal or esophageal cancer who have taken active therapy and are not neck tissue damage.
- Patients with clear conscious and stable mental status
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fiberoptic endoscopic evaluation of swallowing (FEES)
Time frame: Baseline:Within 3-6 months after synptom occurs
Swallowing evaluation
Laryngo-pharyngeal mucosa sensation test
Time frame: Baseline:Within 3-6 months after synptom occurs
There were four probes of different diameters that similar to the Von Frey filament were prepared for the examination. The diameters were 0.07mm, 0.15mm.0.2 mm and 0.3 mm. The mono-filament nylon probe was placed and contact with the tip and arytenoid mucosa.
5 secondary outcomes
laryngeal electromyography
Time frame: Baseline:Within 3-6 months after synptom occurs
laboratory voice analysis
Time frame: Baseline:Within 3-6 months after synptom occurs
voice range profile
Time frame: Baseline:Within 3-6 months after synptom occurs
Voice Handicap Index (VHI)
Time frame: Baseline:Within 3-6 months after synptom occurs
Disease related life quality assessment: FACT-H&N, FACT-E
Time frame: Baseline:Within 3-6 months after synptom occurs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
Related trials for Unilateral Vocal Cord Paralysis
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Enrolling by invitationObservational study
Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Recruiting
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Paralysis, Unilateral, Vocal Cord
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuan-Jen Fang, MD contact
Tuan-Jen Fang, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Vocal Cord Paralysis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuan-Jen Fang, MD (fang3109@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiberoptic endoscopic evaluation of swallowing (FEES) (time frame: Baseline:Within 3-6 months after synptom occurs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.