Clinical trial NCT02243722: Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
Official title: Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unilateral Vocal Cord Paralysis
Keywords: laryngeal electromyography
intrinsic laryngeal muscles
recurrent laryngeal nerve
superior laryngeal nerve
laryngeal sensation
tone language
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from a tertian referral medical center.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fiberoptic endoscopic evaluation of swallowing (FEES)
timeFrame: Baseline:Within 3-6 months after synptom occurs
measure: Laryngo-pharyngeal mucosa sensation test
timeFrame: Baseline:Within 3-6 months after synptom occurs
Secondary outcomes:
measure: laryngeal electromyography
timeFrame: Baseline:Within 3-6 months after synptom occurs
measure: laboratory voice analysis
timeFrame: Baseline:Within 3-6 months after synptom occurs
measure: voice range profile
timeFrame: Baseline:Within 3-6 months after synptom occurs
measure: Voice Handicap Index (VHI)
timeFrame: Baseline:Within 3-6 months after synptom occurs
measure: Disease related life quality assessment: FACT-H&N, FACT-E
timeFrame: Baseline:Within 3-6 months after synptom occurs
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Tuan-Jen Fang, MD
role: PRINCIPAL_INVESTIGATOR
References: