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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Unilateral Vocal Cord Paralysis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

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)



Primary Outcome Measures :
  1. Fiberoptic endoscopic evaluation of swallowing (FEES) [ Time Frame: Baseline:Within 3-6 months after synptom occurs ]
    Swallowing evaluation

  2. 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 Outcome Measures :
  1. laryngeal electromyography [ Time Frame: Baseline:Within 3-6 months after synptom occurs ]
  2. 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) .

  3. 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.

  4. 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.

  5. 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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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from a tertian referral medical center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243722


Contacts
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Contact: Tuan-Jen Fang, MD fang3109@cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Tuan-Jen Fang, MD Chang Gung Memorial Hospital

Additional Information:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02243722     History of Changes
Other Study ID Numbers: 102-5333A3
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: February 2014
Keywords provided by Chang Gung Memorial Hospital:
laryngeal electromyography
intrinsic laryngeal muscles
recurrent laryngeal nerve
superior laryngeal nerve
laryngeal sensation
tone language
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases