Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
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|ClinicalTrials.gov Identifier: NCT02243722|
Recruitment Status : Unknown
Verified February 2014 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : September 18, 2014
Last Update Posted : September 18, 2014
|Condition or disease|
|Unilateral Vocal Cord Paralysis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||70 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||November 2016|
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)
- 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.
- laryngeal electromyography [ Time Frame: Baseline:Within 3-6 months after synptom occurs ]
- laboratory voice analysis [ Time Frame: 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 [ Time Frame: 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.
- Voice Handicap Index (VHI) [ Time Frame: 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.
- Disease related life quality assessment: FACT-H&N, FACT-E [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243722
|Contact: Tuan-Jen Fang, MDemail@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Principal Investigator:||Tuan-Jen Fang, MD||Chang Gung Memorial Hospital|