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

Unilateral Vocal Cord Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243722
• Other study ID #: 102-5333A3
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2014
• Last updated: September 16, 2014
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2014
• Source: Chang Gung Memorial Hospital
• Contact: Tuan-Jen Fang, MD
• Email: fang3109[@]cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fiberoptic endoscopic evaluation of swallowing (FEES)	Swallowing evaluation	Baseline:Within 3-6 months after synptom occurs	No
Primary	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	No
Secondary	laryngeal electromyography		Baseline:Within 3-6 months after synptom occurs	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No