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Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment

Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02243722
Enrollment
70
Registered
2014-09-18
Start date
2014-07-31
Completion date
2016-11-30
Last updated
2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Vocal Cord Paralysis

Keywords

laryngeal electromyography, intrinsic laryngeal muscles, recurrent laryngeal nerve, superior laryngeal nerve, laryngeal sensation, tone language

Brief 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. 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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Fiberoptic endoscopic evaluation of swallowing (FEES)Baseline:Within 3-6 months after synptom occursSwallowing evaluation
Laryngo-pharyngeal mucosa sensation testBaseline:Within 3-6 months after synptom occursThere 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.

Secondary

MeasureTime frameDescription
voice range profileBaseline:Within 3-6 months after synptom occursThe 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.
laryngeal electromyographyBaseline:Within 3-6 months after synptom occurs
Disease related life quality assessment: FACT-H&N, FACT-EBaseline:Within 3-6 months after synptom occursFunctional 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.
Voice Handicap Index (VHI)Baseline:Within 3-6 months after synptom occursVoice-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.
laboratory voice analysisBaseline:Within 3-6 months after synptom occursfundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .

Countries

Taiwan

Contacts

Primary ContactTuan-Jen Fang, MD
fang3109@cgmh.org.tw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026