NCT02184377

Brief Summary

Mandarin Chinese phonemically distinguishes four tones, with Tone 1 having high-level pitch, Tone 2 high-rising pitch, Tone 3 low-dipping pitch, and Tone 4 high-falling pitch The same segmental context carries different meanings depending on the tone. The function deficit of cricothyroid (CT) muscle, innervated by external branch superior laryngeal nerve (eSLN), would impair the speech tone adjustment. The defect in tone adjustment may interfere with the communication function in Mandarin Chinese speaker more than other language users. This may explain while peripheral unilateral vocal fold paralysis (UVFP) patients with eSLN injury had worse outcomes than those with sole recurrent laryngeal nerve paralysis. The neuromuscular control of laryngeal muscle can be evaluated by laryngeal electromyography (LEMG). The investigators have utilized a quantified LEMG (denoted Q-LEMG) in their previous research to measure the neuromuscular control of thyroarytenoid- lateral cricoarytenoid (TA-LCA) adductor complex. However, the task to measure the CT muscle function by Q-LEMG has not been developed yet. It is of thus of utmost interest to develop a standardized task to measure the neuromuscular function of CT muscle in Mandarin speakers. In Mandarin speaking patients with UVFP, the lexical tone influence from CT muscle can be discovered by the technique. The investigators also want to measure the lexical tone correction by conventional laryngoplasty and its influence in CT muscle activity. The data of lexical tone and its correlation with CT contractile activity is important in attempting pitch adjust artificial electrolarynx.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

June 23, 2014

Last Update Submit

July 8, 2014

Conditions

Keywords

quantitative laryngeal electromyographycricothyroid muscleunilateral vocal fold paralysissuperior laryngeal nervelexical toneMandarin

Outcome Measures

Primary Outcomes (1)

  • laryngeal electromyography

    before hyaluronate injection; one month after hyaluronate injection

Secondary Outcomes (4)

  • laboratory voice analysis

    before hyaluronate injection; one month after hyaluronate injection

  • voice outcomes survey (VOS)

    before hyaluronate injection; one month after hyaluronate injection

  • Short form -36

    before hyaluronate injection; one month after hyaluronate injection

  • voice range profile

    before hyaluronate injection; one month after hyaluronate injection

Study Arms (2)

RLN+SLN paralysis

unilateral recurrent laryngeal and superior laryngeal nerve paralysis

RLN paralysis

unilateral recurrent laryngeal nerve paralysis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from a tertian referral medical center.

You may qualify if:

  • Patients with acute unilateral vocal palsy
  • Patients with clear conscious and stable mental status

You may not qualify if:

  • Patients with wounds on the neck or with bleeding disorder or serious cardiopulmonary dysfunction
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Linkuo, Taiwan

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tuan-Jen Fang, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Laryngology

Study Record Dates

First Submitted

June 23, 2014

First Posted

July 9, 2014

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations