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

• Conditions: Unilateral Vocal Cord Paralysis

• Registration Number: NCT02243722
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-02
• Study Start: 2014-07
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-18
• Last Update Posted: 2014-09-18
• Primary Completion: 2016-08
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fiberoptic endoscopic evaluation of swallowing (FEES)	Baseline:Within 3-6 months after synptom occurs	Swallowing evaluation
Laryngo-pharyngeal mucosa sensation test	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 Outcome Measures

Name	Time	Method
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	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.
Voice Handicap Index (VHI)	Baseline:Within 3-6 months after synptom occurs	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.
laboratory voice analysis	Baseline:Within 3-6 months after synptom occurs	fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .
voice range profile	Baseline:Within 3-6 months after synptom occurs	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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan