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Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change

This study has been withdrawn prior to enrollment.
(Study not started)
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Information provided by (Responsible Party):
Hyder A. Jinnah, MD, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT02061943
First received: February 11, 2014
Last updated: May 27, 2016
Last verified: May 2016
  Purpose
This is a study of patients with spasmodic dysphonia to determine how best to measure the severity of the disorder in patients. It addresses which characteristics of speech are the best indicator of whether or not a particular treatment has benefited a person with spasmodic dysphonia. We hope to recruit 20 participants each at 2 different centers. The evaluation for each participant will be done on a two visits, one just before and another several weeks after treatment.

Condition
Spasmodic Dysphonia
Laryngeal Dystonia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validity and Reliability of the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Quantifying Symptom Change

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • SD-DAP [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    Identify items within the SD-DAP that are sensitive to symptom reduction when participants with spasmodic dysphonia are treated with botulinum toxin.


Enrollment: 0
Study Start Date: October 2015
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed Description:

This is a study of changes in voice and laryngeal function with treatment recorded using the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP). Persons with adductor spasmodic dysphonia will complete a questionnaire on the Voice Handicap Index (VHI) and ratings of speech effort as well as have their speech recorded and receive a nasolaryngoscopy examination prior to their usual treatment with botulinum toxin injection into the laryngeal muscles for their voice disorder. They will return for re-examination several weeks later after their injection and repeat each of the examinations. The purpose is to determine which items on the SD-DAP are sensitive to changes in the severity of their voice disorder. The items that show sensitivity would be those that would be useful for assessing voice outcomes in clinical trials. Some of the questions this study is trying to answer are

  • What is the best way to measure the severity of spasmodic dysphonia?
  • How does treatment of spasmodic dysphonia by botulinum toxin injection affect voice for communication in regular daily life in spasmodic dysphonia
  • Is change in speaking effort related to the change in severity of spasmodic dysphonia with botulinum toxin injection?

Each participant in this study will be asked to do the following:

  • Provide a copy of medical records and medical history relating to the diagnosis of spasmodic dysphonia.
  • Have an examination by an otolaryngologist with a medical periscope inserted in the throat to view the voice box in action. The examination will be so it can be reviewed later by several different experts.
  • Complete questionnaires regarding the severity of their disorder before and after receiving their usual treatment; an injection of botulinum toxin into the laryngeal muscles.
  • Repeat a speech recording and laryngeal examination before and after treatment
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with spasmodic dysphonia are eligible for this study.
Criteria

Inclusion Criteria:

  • be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia)
  • be 18 years of age or older

Exclusion Criteria:

  • be diagnosed with secondary spasmodic dysphonia (laryngeal dystonia)
  • be younger than 18 years of age
  • unable to complete questionnaires
  • not able to have a nasolaryngoscopy (examination of the voice box with a medical periscope)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061943

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Office of Rare Diseases (ORD)
Investigators
Principal Investigator: Christy Ludlow, PhD James Madison University
  More Information

Responsible Party: Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02061943     History of Changes
Other Study ID Numbers: IRB00068259  U54NS065701 
Study First Received: February 11, 2014
Last Updated: May 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Spasmodic dysphonia
Laryngeal dystonia
Dystonia
Severity

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dysphonia
Hoarseness
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on December 02, 2016