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Clinical Trials/NCT02243722
NCT02243722
Unknown
N/A

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

Chang Gung Memorial Hospital1 site in 1 country70 target enrollmentJuly 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Unilateral Vocal Cord Paralysis
Sponsor
Chang Gung Memorial Hospital
Enrollment
70
Locations
1
Primary Endpoint
Fiberoptic endoscopic evaluation of swallowing (FEES)
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
November 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • laryngeal electromyography(Baseline:Within 3-6 months after synptom occurs)
  • Disease related life quality assessment: FACT-H&N, FACT-E(Baseline:Within 3-6 months after synptom occurs)
  • Voice Handicap Index (VHI)(Baseline:Within 3-6 months after synptom occurs)
  • laboratory voice analysis(Baseline:Within 3-6 months after synptom occurs)
  • voice range profile(Baseline:Within 3-6 months after synptom occurs)

Study Sites (1)

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