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

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 Overview

• Status: Unknown
• Conditions: Unilateral Vocal Cord Paralysis

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Tuan-Jen Fang, MD; Email: fang3109@cgmh.org.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from a tertian referral medical center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiberoptic endoscopic evaluation of swallowing (FEES)	Swallowing evaluation	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.	Baseline:Within 3-6 months after synptom occurs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
laryngeal electromyography		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) .	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.	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.	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.	Baseline:Within 3-6 months after synptom occurs

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: superior laryngeal nerve; recurrent laryngeal nerve; laryngeal electromyography; intrinsic laryngeal muscles; laryngeal sensation; tone language
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: 102-5333A3