NCT00001922

Brief Summary

This research study is designed to improve understanding about voice disorders that are due to uncontrolled muscle contractions affecting the voice box. The type of voice disorder depends on which muscles of the voice box are involved. Abductor spasmodic dysphonia may lead to a weak voice. Adductor spasmodic dysphonia may result in a strangled voice. Muscular tension dysphonia may lead to a strained voice. Some of the major goals of the study are to;

  1. 1.understand how sensation from the voice box affects voice and speech production
  2. 2.develop better ways to diagnose sensation abnormalities affecting the voice box
  3. 3.determine if patients with voice disorders differ from persons without voice disorders in the way they respond to sensory information from their voice box

Trial Health

80
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 1998

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2009

Completed
Last Updated

July 2, 2017

Status Verified

September 14, 2009

Enrollment Period

10.9 years

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

Evoked ResponseSpasmodic DysphoniaAerodynamicVibrationLaryngealVoice DisordersLaryngeal Brainstem Evoked ResponsesLong-latency ResponsesMuscular Tension Dysphonia

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal volunteers between the ages of 20 and 80 years of age will be selected after a screening examination.
  • Subjects will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by an otolaryngologist.
  • None of the subjects included for study will have a reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm.

You may not qualify if:

  • Any patient with a history of airway obstruction will be excluded from the study.
  • No smokers or tobacco users will be included in the study.
  • Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.
  • Any individual with: 1) an implant or surgical clip - implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis: 2) a foreign body - metal shavings, shrapnel, orthodontic braces, tattoos or permanent eye liner; and/or, 3) any other implanted device or foreign body not listed above that is possibly ferromagnetic will also be excluded from study seven because of contraindications for magnetic resonance imaging.
  • Symptoms present during speech and not apparent at rest.
  • Symptoms less evident during whisper, singing or falsetto.
  • Symptoms become worse with prolonged speaking, practice or anxiety.
  • Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying.
  • Any patient with a history of airway obstruction will be excluded from the study. Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis).
  • Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm.
  • No smokers or tobacco users will be included in the study.
  • Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.
  • Although patients with neurological disorders are excluded, certain focal dystonias which occasionally occur simultaneously with spasmodic dysphonia, will not automatically exclude a patient from participating. The determination will be made at the discretion of the Laryngeal and Speech Section Team.
  • Although structural abnormalities of the larynx will cause a patient to be excluded, those that have had previous laryngeal surgery will not automatically be disqualified if they remain measurably symptomatic with their voice disorder. The determination will be made at the discretion of the Laryngeal and Speech Section Team.
  • Patients whose symptoms vary during their initial interview, and/or who report periods of symptom remission and are atypical of spasmodic dysphonia will not be included.
  • +40 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Sant'Ambrogio G, Mathew OP. Laryngeal receptors and their reflex responses. Clin Chest Med. 1986 Jun;7(2):211-22.

    PMID: 3522068BACKGROUND
  • Sant'Ambrogio G, Anderson JW, Sant'Ambrogio FB, Mathew OP. Response of laryngeal receptors to water solutions of different osmolality and ionic composition. Respir Med. 1991 Jan;85 Suppl A:57-60. doi: 10.1016/s0954-6111(06)80256-8.

    PMID: 2034837BACKGROUND
  • Hansson L, Wollmer P, Dahlback M, Karlsson JA. Regional sensitivity of human airways to capsaicin-induced cough. Am Rev Respir Dis. 1992 May;145(5):1191-5. doi: 10.1164/ajrccm/145.5.1191.

    PMID: 1586064BACKGROUND

MeSH Terms

Conditions

DysphoniaVoice DisordersLaryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

November 5, 1998

Primary Completion

September 14, 2009

Last Updated

July 2, 2017

Record last verified: 2009-09-14

Locations