NCT00001552

Brief Summary

The purpose the study is to determine the genetic causes of specific voice disorders that run in families. Researchers are particularly interested in two conditions;

  1. 1.Spasmodic dysphonia
  2. 2.Vocal fold paralysis

Trial Health

85
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

4 active sites

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

May 22, 1996

Completed
3.5 years 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
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2009

Completed
Last Updated

July 2, 2017

Status Verified

November 13, 2009

Enrollment Period

13.5 years

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

Spasmodic DysphoniaPedigreeVocal Fold ParalysisVoice Disorder

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from the 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Kennedy-Galton Centre Medical & Community Genetics

Harrow, United Kingdom

Location

Institute of Cancer Research

Sutton, United Kingdom

Location

Related Publications (3)

  • Conway D, Bain PG, Warner TT, Davis MB, Findley LJ, Thompson PD, Marsden CD, Harding AE. Linkage analysis with chromosome 9 markers in hereditary essential tremor. Mov Disord. 1993 Jul;8(3):374-6. doi: 10.1002/mds.870080324.

    PMID: 8341306BACKGROUND
  • Durr A, Stevanin G, Jedynak CP, Penet C, Agid Y, Brice A. Familial essential tremor and idiopathic torsion dystonia are different genetic entities. Neurology. 1993 Nov;43(11):2212-4. doi: 10.1212/wnl.43.11.2212.

    PMID: 8232931BACKGROUND
  • Dyck PJ, Litchy WJ, Minnerath S, Bird TD, Chance PF, Schaid DJ, Aronson AE. Hereditary motor and sensory neuropathy with diaphragm and vocal cord paresis. Ann Neurol. 1994 May;35(5):608-15. doi: 10.1002/ana.410350515.

    PMID: 8179305BACKGROUND

MeSH Terms

Conditions

Laryngeal DiseasesDysphoniaVoice Disorders

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

May 22, 1996

Primary Completion

November 13, 2009

Last Updated

July 2, 2017

Record last verified: 2009-11-13

Locations