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

NCT02243722 | Unknown DMC

• 1 other identifier: 102-5333A3
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Vocal Cord Paralysis

Keywords

laryngeal electromyography; intrinsic laryngeal muscles; recurrent laryngeal nerve; superior laryngeal nerve; laryngeal sensation; tone language

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• laryngeal electromyography

  Baseline:Within 3-6 months after synptom occurs

• laboratory voice analysis

  Baseline:Within 3-6 months after synptom occurs

• voice range profile

  Baseline:Within 3-6 months after synptom occurs

• Voice Handicap Index (VHI)

  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

Study Arms (1)

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)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from a tertian referral medical center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tuan-Jen Fang, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuan-Jen Fang, MD

CONTACT

fang3109@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 18, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 18, 2014

Record last verified: 2014-02

Locations

TW (1)